Luma Wrap
FDA 510(k) clearance K142416 · decided 2015-06-12
Clearance details
- K-number
- K142416
- Device name
- Luma Wrap
- Applicant
- Salter Labs
- Decision
- Substantially Equivalent
- Date received
- 2014-08-28
- Decision date
- 2015-06-12
- Days to decision
- 288 days
- Clearance type
- Traditional
- Product code
- PDH
- Device class
- 2
- Regulation number
- 880.5700
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Carlsbad, CA, 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 |
|---|---|---|
| LITTLE ANGELS SWADDLING BLANKET (K123411) | Bionix Development Corp. | 2013-03-07 |
Recalls involving this device
No recalls on record reference this clearance.