FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RESPITRAK
K Number: K884959
·
Decision Jun 8, 1989
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
60
Applicant Total
6
Review Days
191
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
- RESPITRAK
- K Number
- K884959
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1850
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Non-Invasive Monitoring Systems, Inc.
- Date Received
- November 29, 1988
- Decision Date
- June 8, 1989
- Product Code
- BZK
- 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 |
|---|---|---|---|
| BZK | Spirometer, Monitoring (W/Wo Alarm) | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZK), ordered by most recent decision date.
BEACON Caresystem Model 00002144
FDA 510(k)
FDA Class 2
·Anesthesiology
ExSpiron 2Xi
FDA 510(k)
FDA Class 2
·Anesthesiology
Gas Module 3
FDA 510(k)
FDA Class 2
·Anesthesiology
ExSpiron 1Xi
FDA 510(k)
FDA Class 2
·Anesthesiology
ExSpiron 1Xi
FDA 510(k)
FDA Class 2
·Anesthesiology
EXSPIRON 1XI
FDA 510(k)
FDA Class 2
·Anesthesiology
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 |
| K903011 | RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL | Mar 29, 1991 | Substantially Equivalent |