A Breathing System (ABS)— 510(k) K233580
Substantially EquivalentDeepwell Dtx, Inc.
FDA 510(k) clearance K233580 for A Breathing System (ABS), Substantially Equivalent on 2024-08-01. Applicant: Deepwell Dtx, Inc.. Device class: 2.
Clearance details
- Applicant
- Deepwell Dtx, Inc.
- Product code
- Code HCC
- Device class
- Class 2
- Regulation
- 21 CFR 882.5050
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seattle, WA, US
Recent devices under product code HCC
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