INCENTIVE SPIROMETER— 510(k) K000314
Substantially EquivalentEngineered Medical Systems
FDA 510(k) clearance K000314 for INCENTIVE SPIROMETER, Substantially Equivalent on 2000-04-12. Applicant: Engineered Medical Systems. Device class: 2.
Clearance details
- Applicant
- Engineered Medical Systems
- Product code
- Code BWF
- Device class
- Class 2
- Regulation
- 21 CFR 868.5690
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code BWF
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