AIRWATCH MONITOR— 510(k) K941226
Substantially EquivalentEnact Health Management Systems
FDA 510(k) clearance K941226 for AIRWATCH MONITOR, Substantially Equivalent on 1994-11-16. Applicant: Enact Health Management Systems. Device class: 2.
Clearance details
- Applicant
- Enact Health Management Systems
- Product code
- Code BZH
- Device class
- Class 2
- Regulation
- 21 CFR 868.1860
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Attleboro, MA, US
Recent devices under product code BZH
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