FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFIED BIOLOG
K Number: K915624
·
Decision Mar 27, 1992
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
338
Applicant Total
6
Review Days
113
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Basic Information
- Device Name
- MODIFIED BIOLOG
- K Number
- K915624
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Micromedical Industries, Ltd.
- Date Received
- December 5, 1991
- Decision Date
- March 27, 1992
- Product Code
- DRT
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | FDA class 2 | Cardiovascular |
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Other Clearances by Micromedical Industries, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K013311 | MODIFICATION TO: POCKETVIEW ECG SOFTWARE | Jan 3, 2002 | Substantially Equivalent |
| K012540 | BLY-501 ADAPTOR | Sep 26, 2001 | Substantially Equivalent |
| K990266 | MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE | Feb 2, 1999 | Substantially Equivalent |
| K922528 | CMS SYSTEM | May 12, 1995 | Substantially Equivalent |
| K915627 | PACEVIEW | Mar 27, 1992 | Substantially Equivalent |