SERIES 602 CKG RECORDER (MODIFIED)— 510(k) K801485
Substantially EquivalentCardio Kinetics, Inc.
FDA 510(k) clearance K801485 for SERIES 602 CKG RECORDER (MODIFIED), Substantially Equivalent on 1980-07-08. Applicant: Cardio Kinetics, Inc.. Device class: 1.
Clearance details
- Applicant
- Cardio Kinetics, Inc.
- Product code
- Code DSF
- Device class
- Class 1
- Regulation
- 21 CFR 870.2810
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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