HALA'TUS 1 OXYGENATOR— 510(k) K903504
Substantially EquivalentThe Henry G. Dietz Co., Inc.
FDA 510(k) clearance K903504 for HALA'TUS 1 OXYGENATOR, Substantially Equivalent on 1991-01-28. Applicant: The Henry G. Dietz Co., Inc.. Device class: 2.
Clearance details
- Applicant
- The Henry G. Dietz Co., Inc.
- Product code
- Code NFB
- Device class
- Class 2
- Regulation
- 21 CFR 868.5905
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Long Island City, NY, US
Recent devices under product code NFB
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