PB100 DIAGNOSTIC SPIROMETER— 510(k) K911143
Substantially EquivalentPuritan Bennett Corp.
FDA 510(k) clearance K911143 for PB100 DIAGNOSTIC SPIROMETER, Substantially Equivalent on 1991-11-29. Applicant: Puritan Bennett Corp.. Device class: 2.
Clearance details
- Applicant
- Puritan Bennett Corp.
- Product code
- Code BZM
- Device class
- Class 2
- Regulation
- 21 CFR 868.1900
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Overland Park, KS, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.