MEDNOVA SAFETY BAG
FDA 510(k) clearance K853075 · decided 1985-10-16
Clearance details
- K-number
- K853075
- Device name
- MEDNOVA SAFETY BAG
- Applicant
- Mednova Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-07-23
- Decision date
- 1985-10-16
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- LHI
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Mednova Corp.
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.
Recalls involving this device
No recalls on record reference this clearance.