SLIT CAMERA MODEL 07-624
FDA 510(k) clearance K851811 · decided 1985-05-28
Clearance details
- K-number
- K851811
- Device name
- SLIT CAMERA MODEL 07-624
- Applicant
- Victoreen, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-04-26
- Decision date
- 1985-05-28
- Days to decision
- 32 days
- Clearance type
- Traditional
- Product code
- IXH
- Device class
- 1
- Regulation number
- 892.1940
- 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.
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|---|---|---|
| MY BREAST FRIEND, BREAST SELF-EXAM PAD (K023390) | Mbf Sales, LLC | 2002-11-26 |
Recalls involving this device
No recalls on record reference this clearance.