ESA CAMERA
FDA 510(k) clearance K823516 · decided 1982-12-30
Clearance details
- K-number
- K823516
- Device name
- ESA CAMERA
- Applicant
- Concept, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-11-29
- Decision date
- 1982-12-30
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- FWH
- Device class
- 1
- Regulation number
- 878.4160
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Concept
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MEDICAL DYNAMICS SOLID STATE VIDEO CAMERA 5940 (K884039) | Medical Dynamics, Inc. | 1988-10-13 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HUNTER-SESSIONS VENA-CAVA OCCLUDER (P770005) | Concept, Inc. | 1977-12-19 |