SPIROMETRICS BREON 2400 & SMI 2400— 510(k) K831497
Substantially EquivalentSpirometrics, Inc.
FDA 510(k) clearance K831497 for SPIROMETRICS BREON 2400 & SMI 2400, Substantially Equivalent on 1983-06-24. Applicant: Spirometrics, Inc.. Device class: 2.
Clearance details
- Applicant
- Spirometrics, Inc.
- Product code
- Code BZG
- Device class
- Class 2
- Regulation
- 21 CFR 868.1840
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code BZG
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