FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MOFIFICATION BEAR NVM-1 NEONATAL VOLUME MONITOR
K Number: K890724
·
Decision Mar 30, 1989
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
60
Applicant Total
28
Review Days
45
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
- MOFIFICATION BEAR NVM-1 NEONATAL VOLUME MONITOR
- K Number
- K890724
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1850
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Bear Medical Systems, Inc.
- Date Received
- February 13, 1989
- Decision Date
- March 30, 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 Bear Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K992788 | BEAR CUB 750 PSV | Sep 16, 1999 | Substantially Equivalent |
| K983981 | BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET ET TUBE | Nov 20, 1998 | Substantially Equivalent |
| K912619 | BEAR 7 VENTILATOR | Jun 11, 1992 | Substantially Equivalent |
| K900637 | BEAR CEM CONTROLLER | Aug 3, 1990 | Substantially Equivalent |
| K896315 | BEAR VH820 DISPOSABLE CHAMBER ASSEMBLY | Jan 22, 1990 | Substantially Equivalent |
| K893034 | VHS 820 HUMIDIFIER, MODIFICATION | Jul 14, 1989 | Substantially Equivalent |
| K882764 | BEAR EVC-100 CONTROLLER | Sep 30, 1988 | Substantially Equivalent |
| K881335 | BEAR 3 VENTILATOR | Aug 4, 1988 | Substantially Equivalent |
| K872660 | BEAR NVM-1 | Feb 12, 1988 | Substantially Equivalent |
| K873634 | BEAR VH-820 HUMIDIFIER | Dec 2, 1987 | Substantially Equivalent |