DRAGER ORM— 510(k) K790334
Substantially EquivalentDraeger Medical, Inc.
FDA 510(k) clearance K790334 for DRAGER ORM, Substantially Equivalent on 1979-03-07. Applicant: Draeger Medical, Inc.. Device class: 1.
Clearance details
- Applicant
- Draeger Medical, Inc.
- Product code
- Code BYR
- Device class
- Class 1
- Regulation
- 21 CFR 868.2875
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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