FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ULTRASOUND IMAGING SYSTEM
K Number: K780993
·
Decision Aug 10, 1978
Classifications
1
FEI Numbers
656
Registration Numbers
656
Same Product Code
99
Applicant Total
340
Review Days
57
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Basic Information
- Device Name
- ULTRASOUND IMAGING SYSTEM
- K Number
- K780993
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Boehringer Mannheim Corp.
- Date Received
- June 14, 1978
- Decision Date
- August 10, 1978
- Product Code
- GAD
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| GAD | Retractor | FDA class 1 | General, Plastic Surgery |
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| K983185 | BOEHRINGER MANNHEIM TINA-QUANT IGE TEST | Nov 12, 1998 | Substantially Equivalent |
| K982949 | ELECSYS PSA, MODEL 2010 | Oct 27, 1998 | Substantially Equivalent |