SPIROSCOPE— 510(k) K905480
Substantially EquivalentGrandcor Medical Systems
FDA 510(k) clearance K905480 for SPIROSCOPE, Substantially Equivalent on 1991-05-06. Applicant: Grandcor Medical Systems. Device class: 2.
Clearance details
- Applicant
- Grandcor Medical Systems
- Product code
- Code BZC
- Device class
- Class 2
- Regulation
- 21 CFR 868.1880
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dayton, OH, US
Recent devices under product code BZC
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