ISO-100 ISOLATION AMPLIFIER
FDA 510(k) clearance K883947 · decided 1988-12-05
Clearance details
- K-number
- K883947
- Device name
- ISO-100 ISOLATION AMPLIFIER
- Applicant
- Telediagnostic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-09-19
- Decision date
- 1988-12-05
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- GYE
- Device class
- 2
- Regulation number
- 882.1855
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- San Francisco, CA, 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 |
| 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 |
| BRAEGEN III 10-CHANNEL TRANSMITTER- (K832304) | Electro-Bio-Medical Services, Inc. | 1983-08-31 |
Recalls involving this device
No recalls on record reference this clearance.