FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BICORE SMARTVALVE OCCLUSION VALVE
K Number: K921717
·
Decision Nov 6, 1992
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
60
Applicant Total
4
Review Days
211
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
- BICORE SMARTVALVE OCCLUSION VALVE
- K Number
- K921717
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1850
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bicore Monitoring Systems
- Date Received
- April 9, 1992
- Decision Date
- November 6, 1992
- 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