SPIROCARD— 510(k) K973138
Substantially EquivalentQrs Diagnostic, LLC
FDA 510(k) clearance K973138 for SPIROCARD, Substantially Equivalent on 1998-10-28. Applicant: Qrs Diagnostic, LLC. Device class: 2.
Clearance details
- Applicant
- Qrs Diagnostic, LLC
- 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
- Plymouth, MN, US
Recent devices under product code BZG
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