FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PFIZONIC 300 ULTRASOUND SCANNER
K Number: K802532
·
Decision Dec 18, 1980
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
12
Review Days
63
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Basic Information
- Device Name
- PFIZONIC 300 ULTRASOUND SCANNER
- K Number
- K802532
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Pfizer Medical Systems, Inc.
- Date Received
- October 16, 1980
- Decision Date
- December 18, 1980
- Product Code
- IYO
- 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | FDA class 2 | Radiology |
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Other Clearances by Pfizer Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K803032 | PFIZER PZ-SLM RAD. THERAPY TRTMT. SIMUL. | Jan 22, 1981 | Substantially Equivalent |
| K802529 | PFIZONIC 100 ULTRASOUND SCANNER | Dec 18, 1980 | Substantially Equivalent |
| K802528 | PFIZONIC 150 ULTRASOUND SCANNER | Dec 18, 1980 | Substantially Equivalent |
| K802531 | PFIZONIC 200 ULTRASOUND SCANNER | Dec 18, 1980 | Substantially Equivalent |
| K802530 | PFIZONIC 250 ULTRASOUND SCANNER | Dec 18, 1980 | Substantially Equivalent |
| K801446 | PFIZER PZ-CT SCANNER | Jul 28, 1980 | Substantially Equivalent |
| K800501 | PFIZER/AS&E 0450 LOCALIZER | Apr 10, 1980 | Substantially Equivalent |
| K781752 | SCANNER, CT 0450 | Nov 3, 1978 | Substantially Equivalent |
| K780278 | RADIATION THERAPY TREAT. PLAN. SYS. | Mar 2, 1978 | Substantially Equivalent |
| K772289 | SCANNER, CT, 0400 | Dec 21, 1977 | Substantially Equivalent |