HARDWARE:CARDIO PERFECT PORTABLE, CARDIO PERFECT MD AND SOFTWARE:CARDIO PERFECT (V. 4.0 AND UP FOR DOS), CARDIO PERFECT
FDA 510(k) clearance K962854 · decided 1997-01-27
Clearance details
- K-number
- K962854
- Device name
- HARDWARE:CARDIO PERFECT PORTABLE, CARDIO PERFECT MD AND SOFTWARE:CARDIO PERFECT (V. 4.0 AND UP FOR DOS), CARDIO PERFECT
- Applicant
- Cardio Control BV
- Decision
- Substantially Equivalent
- Date received
- 1996-07-22
- Decision date
- 1997-01-27
- Days to decision
- 189 days
- Clearance type
- Traditional
- Product code
- LOS
- Advisory committee
- Unknown
- Location
- Atlanta, GA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.