MODEL SP 5507 5-LUMEN THERMODILUTION CAT— 510(k) K811537
Substantially EquivalentGould, Inc.
FDA 510(k) clearance K811537 for MODEL SP 5507 5-LUMEN THERMODILUTION CAT, Substantially Equivalent on 1981-06-18. Applicant: Gould, Inc.. Device class: 2.
Clearance details
- Applicant
- Gould, Inc.
- Product code
- Code KRB
- Device class
- Class 2
- Regulation
- 21 CFR 870.1915
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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