FDA 510(k)
Substantially Equivalent
🇺🇸 United States
CARDIO-CARD INTERPRETATION SYSTEM I
K Number: K993616
·
Decision Apr 10, 2000
Classifications
0
FEI Numbers
11
Registration Numbers
11
Same Product Code
82
Applicant Total
5
Review Days
167
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CARDIO-CARD INTERPRETATION SYSTEM I
- K Number
- K993616
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Nasiff Assoc., Inc.
- Date Received
- October 26, 1999
- Decision Date
- April 10, 2000
- 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 Nasiff Assoc., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972795 | CARDIO-CARD MANAGEMENT SYSTEM II | Feb 20, 1998 | Substantially Equivalent |
| K960544 | CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEM | Aug 7, 1996 | Substantially Equivalent |
| K920020 | CARDIO-CARD ECG MANAGEMENT SYSTEM | Jul 9, 1992 | Substantially Equivalent |
| K903722 | MICROMED QRS CARD | Dec 5, 1990 | Substantially Equivalent |