G.E. TELEMETRY MONITORING
FDA 510(k) clearance K761259 · decided 1976-12-21
Clearance details
- K-number
- K761259
- Device name
- G.E. TELEMETRY MONITORING
- Applicant
- General Electric Co.
- Decision
- Substantially Equivalent
- Date received
- 1976-12-15
- Decision date
- 1976-12-21
- Days to decision
- 6 days
- Clearance type
- Traditional
- Product code
- GYE
- Device class
- 2
- Regulation number
- 882.1855
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| WIRELESS EEG RECORDING SYSTEM MODEL W32 (K963195) | Cme Telemetrix, Inc. | 1997-07-29 |
| DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER (K970659) | Telediagnostic Systems, Inc. | 1997-05-16 |
| MODEL 219 TELEMETRY SYSTEM (K895895) | Mennen Medical, Inc. | 1990-02-22 |
| BMS-2000 MOBILE EEG SYSTEM (K891405) | Buckman Co., Inc. | 1989-08-02 |
| RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER (K885328) | Telediagnostic Systems, Inc. | 1989-03-22 |
| ISO-100 ISOLATION AMPLIFIER (K883947) | Telediagnostic Systems, Inc. | 1988-12-05 |
| DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIES (K883461) | Biohm, Inc. | 1988-11-30 |
| S-10 TELEPHONIC POLYSOMNOGRAPH (K874257) | Telediagnostic Systems, Inc. | 1987-12-11 |
| M10 EEG MONITOR SCOPE (K871120) | Telediagnostic Systems, Inc. | 1987-05-01 |
| MODAC-XXXX INTENSIVE MONITORING OF EEG (K860128) | Grass-Telefactor Product Group | 1986-03-27 |
| TELEPHONIC RECEIVER R-10 EEG (K833880) | Pharmaquest Corp. | 1983-11-29 |
| TELEPHONE TRANSMITTER T-10 EEG (K833236) | Pharmaquest Corp. | 1983-11-29 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S017) | General Electric Co. | 1988-07-29 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S013) | General Electric Co. | 1988-07-15 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S016) | General Electric Co. | 1988-06-30 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S014) | General Electric Co. | 1988-05-05 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S015) | General Electric Co. | 1988-05-02 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S012) | General Electric Co. | 1987-11-25 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S011) | General Electric Co. | 1987-06-18 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S010) | General Electric Co. | 1987-03-30 |