FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
HDM97
K Number: K020908
·
Decision May 22, 2002
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
12
Applicant Total
3
Review Days
63
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Basic Information
- Device Name
- HDM97
- K Number
- K020908
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ibp Instruments GmbH
- Date Received
- March 20, 2002
- Decision Date
- May 22, 2002
- Product Code
- FIZ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FIZ | Meter, Conductivity, Non-Remote | FDA class 2 | Gastroenterology, Urology |
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