FDA 510(k)
Substantially Equivalent
🇺🇸 United States
CARDIOVIEW 3000 SOFTWARE
K Number: K974352
·
Decision Sep 8, 1998
Classifications
0
FEI Numbers
11
Registration Numbers
11
Same Product Code
82
Applicant Total
5
Review Days
293
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Basic Information
- Device Name
- CARDIOVIEW 3000 SOFTWARE
- K Number
- K974352
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Micromedical, Inc.
- Date Received
- November 19, 1997
- Decision Date
- September 8, 1998
- 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 Micromedical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K974220 | MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE | Aug 25, 1998 | Substantially Equivalent |
| K974351 | BIOLOG 3000 ELECTROCARDIOGRAPH | Apr 1, 1998 | Substantially Equivalent |
| K970305 | PRINTER INTERFACE | Aug 15, 1997 | Substantially Equivalent |
| K955891 | CARDIOVIEW TRANSTELEPHONIC SOFTWARE | Oct 8, 1996 | Substantially Equivalent |