MEDIKEEPER
FDA 510(k) clearance K912346 · decided 1991-07-30
Clearance details
- K-number
- K912346
- Device name
- MEDIKEEPER
- Applicant
- Medikeeper, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-05-28
- Decision date
- 1991-07-30
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- BRY
- Device class
- 1
- Regulation number
- 868.6100
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Philadelphia, PA, 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 |
|---|---|---|
| MOVIT DEVICE (K921710) | John J. Navar, M.D. | 1992-06-29 |
| ANESTHESIA WORKSTATION (K901474) | Siemens Life Support Systems | 1990-04-10 |
| ANESTHASSIST (K871564) | Anestech, Inc. | 1987-05-18 |
| ANESTHECACHE (K821307) | Med-Life, Inc. | 1982-05-14 |
Recalls involving this device
No recalls on record reference this clearance.