FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPIROLOOP, MODIFICATION
K Number: K904633
·
Decision Mar 12, 1991
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
27
Applicant Total
3
Review Days
168
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
- SPIROLOOP, MODIFICATION
- K Number
- K904633
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1430
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Pneumedics, Inc.
- Date Received
- September 25, 1990
- Decision Date
- March 12, 1991
- Product Code
- CCJ
- 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 |
|---|---|---|---|
| CCJ | Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CCJ), ordered by most recent decision date.
CoSense ETCO Monitor
FDA 510(k)
FDA Class 2
·Anesthesiology
iCOquit® Smokerlyzer®
FDA 510(k)
FDA Class 2
·Anesthesiology
Pivot Breath Sensor
FDA 510(k)
FDA Class 2
·Anesthesiology
ToxCO
FDA 510(k)
FDA Class 2
·Anesthesiology
CO Check Pro, CO Screen
FDA 510(k)
FDA Class 2
·Anesthesiology
Carbon Monoxide Breath Sensor System (COBSS)
FDA 510(k)
FDA Class 2
·Anesthesiology