37-701-1 PATIENT DOASE MONITOR WITH DETECTORS
FDA 510(k) clearance K860469 · decided 1986-04-16
Clearance details
- K-number
- K860469
- Device name
- 37-701-1 PATIENT DOASE MONITOR WITH DETECTORS
- Applicant
- Victoreen, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-02-06
- Decision date
- 1986-04-16
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- KPZ
- Device class
- 2
- Regulation number
- 892.5900
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Carle Place, NY, 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 |
|---|---|---|
| PATIENT DOSE MONITOR (K912249) | Theta Systems, Inc. | 1991-08-30 |
| VERIFLEX (K854410) | Old Delft Corp. of America | 1986-02-12 |
Recalls involving this device
No recalls on record reference this clearance.