FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GEM, MODEL 004110
K Number: K030464
·
Decision Mar 14, 2003
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
227
Applicant Total
4
Review Days
30
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
- GEM, MODEL 004110
- K Number
- K030464
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.1840
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Collins Medical, Inc.
- Date Received
- February 12, 2003
- Decision Date
- March 14, 2003
- Product Code
- BZG
- 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 |
|---|---|---|---|
| BZG | Spirometer, Diagnostic | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZG), ordered by most recent decision date.
MESI mTABLET SPIRO
FDA 510(k)
FDA Class 2
·Anesthesiology
TD-7301 Spirometer (TD-7301)
FDA 510(k)
FDA Class 2
·Anesthesiology
Air Next (NVD-02)
FDA 510(k)
FDA Class 2
·Anesthesiology
Spirobank Oxi
FDA 510(k)
FDA Class 2
·Anesthesiology
EasyOne Sky Spirometer
FDA 510(k)
FDA Class 2
·Anesthesiology
Alveoair Digital Spirometer
FDA 510(k)
FDA Class 2
·Anesthesiology