AIROS 8 Sequential Compression Device— 510(k) K193068
Substantially EquivalentAiros Medical, Inc.
FDA 510(k) clearance K193068 for AIROS 8 Sequential Compression Device, Substantially Equivalent on 2019-12-04. Applicant: Airos Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Airos Medical, Inc.
- Product code
- Code JOW
- Device class
- Class 2
- Regulation
- 21 CFR 870.5800
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Audubon, PA, US
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