PATIENT DOSE MONITOR
FDA 510(k) clearance K912249 · decided 1991-08-30
Clearance details
- K-number
- K912249
- Device name
- PATIENT DOSE MONITOR
- Applicant
- Theta Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-05-21
- Decision date
- 1991-08-30
- Days to decision
- 101 days
- Clearance type
- Traditional
- Product code
- KPZ
- Device class
- 2
- Regulation number
- 892.5900
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Melbourne, FL, 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 |
|---|---|---|
| 37-701-1 PATIENT DOASE MONITOR WITH DETECTORS (K860469) | Victoreen, Inc. | 1986-04-16 |
| VERIFLEX (K854410) | Old Delft Corp. of America | 1986-02-12 |
Recalls involving this device
No recalls on record reference this clearance.