FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RESPITRACE PT
K Number: K942852
·
Decision Feb 13, 1996
Classifications
1
FEI Numbers
178
Registration Numbers
178
Same Product Code
429
Applicant Total
6
Review Days
610
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Basic Information
- Device Name
- RESPITRACE PT
- K Number
- K942852
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1425
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Non-Invasive Monitoring Systems, Inc.
- Date Received
- June 13, 1994
- Decision Date
- February 13, 1996
- Product Code
- DQK
- 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 |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | FDA class 2 | Cardiovascular |
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Other Clearances by Non-Invasive Monitoring Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K012020 | RESPIEVENTS SOFTWARE IS EVENT DATA PROCESSING SOFWARE FOR A PC | Aug 21, 2001 | Substantially Equivalent |
| K001369 | RESPIEVENTS, VERSION 4.2 | Jul 26, 2000 | Substantially Equivalent |
| K942771 | RESPIEVENTS | Feb 13, 1996 | Substantially Equivalent |
| K903011 | RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL | Mar 29, 1991 | Substantially Equivalent |
| K884959 | RESPITRAK | Jun 8, 1989 | Substantially Equivalent |