ScanX Barrier Envelopes
FDA 510(k) clearance K190949 · decided 2019-07-26
Clearance details
- K-number
- K190949
- Device name
- ScanX Barrier Envelopes
- Applicant
- Air Techniques, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-04-11
- Decision date
- 2019-07-26
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- PEM
- Device class
- 2
- Regulation number
- 878.4370
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Melville, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.