BMS-2000 MOBILE EEG SYSTEM
FDA 510(k) clearance K891405 · decided 1989-08-02
Clearance details
- K-number
- K891405
- Device name
- BMS-2000 MOBILE EEG SYSTEM
- Applicant
- Buckman Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-03-14
- Decision date
- 1989-08-02
- Days to decision
- 141 days
- Clearance type
- Traditional
- Product code
- GYE
- Device class
- 2
- Regulation number
- 882.1855
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Martinez, CA, US
- Third-party review
- No
- Expedited review
- No
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| ISO-100 ISOLATION AMPLIFIER (K883947) | Telediagnostic Systems, Inc. | 1988-12-05 |
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| 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
| Record | Firm | Date |
|---|---|---|
| BMSI "MicroJack" PN 672-510000 patient interface electrode connection device used during e recall (Z-1225-2007) | Nicolet Biomedical Div of Viasys Healthcare | 2007-09-20 |