FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MODEL PCX/EMY 525A MICROPROCESSSOR CONTROL X-RAY C
K Number: K850761
·
Decision Sep 19, 1985
Classifications
1
FEI Numbers
135
Registration Numbers
135
Same Product Code
7
Applicant Total
14
Review Days
206
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Basic Information
- Device Name
- MODEL PCX/EMY 525A MICROPROCESSSOR CONTROL X-RAY C
- K Number
- K850761
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.6175
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Medicor USA , Ltd.
- Date Received
- February 25, 1985
- Decision Date
- September 19, 1985
- Product Code
- BZN
- Advisory Committee
- Anesthesiology
- 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 |
|---|---|---|---|
| BZN | Cart, Emergency, Cardiopulmonary (Excluding Equipment) | FDA class 1 | Anesthesiology |
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Other Clearances by Medicor USA , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K861994 | MODEL RS-3I RADIOGRAPHIC/FLUROSCOPIC X-RAY SYSTEM | Jul 18, 1986 | Substantially Equivalent |
| K861995 | MODEL RS-3 RADIOGRAPHIC STAND | Jun 19, 1986 | Substantially Equivalent |
| K860025 | MODEL MS-325 RADIOGRAPHIC X-RAY GENERATOR | May 7, 1986 | Substantially Equivalent |
| K851358 | MODEL BION 2/TYPE 90 ROOM IONIZER | Jul 1, 1985 | Substantially Equivalent |
| K851094 | MODEL BION 1/TYPE 1084T CAR IONIZER | Jun 19, 1985 | Substantially Equivalent |
| K843335 | FLOOR MOUNTED X-RAY TUBESTAND | Nov 27, 1984 | Substantially Equivalent |
| K840227 | UROLIX-3 UROLOGICAL TABLE | Mar 23, 1984 | Substantially Equivalent |
| K840225 | C-ARM CEILING CRANE FT-2 | Mar 22, 1984 | Substantially Equivalent |
| K840226 | MOTOR TILTED EXAM. TABLE UV-56 | Mar 16, 1984 | Substantially Equivalent |
| K823695 | CPM METABOLIC MONITOR | Jan 14, 1983 | Substantially Equivalent |