SPIRO'AIR— 510(k) K042595
Substantially EquivalentMorgan Scientific, Inc.
FDA 510(k) clearance K042595 for SPIRO'AIR, Substantially Equivalent on 2005-05-04. Applicant: Morgan Scientific, Inc.. Device class: 2.
Clearance details
- Applicant
- Morgan Scientific, 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
- Haverhill, MA, US
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