FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL
K Number: K903011
·
Decision Mar 29, 1991
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
174
Applicant Total
6
Review Days
263
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Basic Information
- Device Name
- RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL
- K Number
- K903011
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Non-Invasive Monitoring Systems, Inc.
- Date Received
- July 9, 1990
- Decision Date
- March 29, 1991
- Product Code
- BZQ
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BZQ | Monitor, Breathing Frequency | FDA class 2 | Anesthesiology |
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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 |
| K942852 | RESPITRACE PT | Feb 13, 1996 | Substantially Equivalent |
| K942771 | RESPIEVENTS | Feb 13, 1996 | Substantially Equivalent |
| K884959 | RESPITRAK | Jun 8, 1989 | Substantially Equivalent |