FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPIROTECH ST-5500
K Number: K823770
·
Decision Jun 3, 1983
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
227
Applicant Total
3
Review Days
171
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Basic Information
- Device Name
- SPIROTECH ST-5500
- K Number
- K823770
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1840
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Spirotech, Inc.
- Date Received
- December 14, 1982
- Decision Date
- June 3, 1983
- 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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