FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GEM; HAWK; EAGLE; MODELS 004110, 0044120, 004130
K Number: K030917
·
Decision May 14, 2003
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
227
Applicant Total
4
Review Days
51
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Basic Information
- Device Name
- GEM; HAWK; EAGLE; MODELS 004110, 0044120, 004130
- K Number
- K030917
- 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
- March 24, 2003
- Decision Date
- May 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 |
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