ScanX Barrier Envelopes— 510(k) K190949
Substantially EquivalentAir Techniques, Inc.
FDA 510(k) clearance K190949 for ScanX Barrier Envelopes, Substantially Equivalent on 2019-07-26. Applicant: Air Techniques, Inc.. Device class: 2.
Clearance details
- Applicant
- Air Techniques, Inc.
- Product code
- Code PEM
- Device class
- Class 2
- Regulation
- 21 CFR 878.4370
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Melville, NY, US
Recent devices under product code PEM
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