FDA 510(k)
Substantially Equivalent
🇳🇱 Netherlands
CARDIO PERFECT, CARDIO PERFECT MD
K Number: K922898
·
Decision Nov 1, 1993
Classifications
0
FEI Numbers
11
Registration Numbers
11
Same Product Code
82
Applicant Total
4
Review Days
503
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Basic Information
- Device Name
- CARDIO PERFECT, CARDIO PERFECT MD
- K Number
- K922898
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cardio Control BV
- Date Received
- June 16, 1992
- Decision Date
- November 1, 1993
- Product Code
- LOS
- Advisory Committee
- Unknown
- Review Advisory Committee
- CV
- Third Party
- N
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LOS), ordered by most recent decision date.
Other Clearances by Cardio Control BV
| K Number | Device Name | ||
|---|---|---|---|
| K962854 | HARDWARE:CARDIO PERFECT PORTABLE, CARDIO PERFECT MD AND SOFTWARE:CARDIO PERFECT (V. 4.0 AND UP FOR DOS), CARDIO PERFECT | Jan 27, 1997 | Substantially Equivalent |
| K935732 | CARDIO PERFECT ST 2001 | Apr 4, 1996 | Substantially Equivalent |
| K913374 | CARDIO PERFECT, CARDIO PERFECT MD | Jan 23, 1992 | Substantially Equivalent |