FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INHAMATIC 33
K Number: K781742
·
Decision Dec 4, 1978
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
29
Applicant Total
5
Review Days
48
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Basic Information
- Device Name
- INHAMATIC 33
- K Number
- K781742
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1320
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Medimatic
- Date Received
- October 17, 1978
- Decision Date
- December 4, 1978
- Product Code
- IZD
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IZD | Probe, Uptake, Nuclear | FDA class 1 | Radiology |
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