FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PAXIAL
K Number: K853116
·
Decision Oct 31, 1985
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
11
Review Days
98
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Basic Information
- Device Name
- PAXIAL
- K Number
- K853116
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Biophysic Medical, Inc.
- Date Received
- July 25, 1985
- Decision Date
- October 31, 1985
- 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 Biophysic Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K953399 | NEEDLE OR CUTTER | Oct 30, 1995 | Substantially Equivalent |
| K893035 | OPHTHASCAN 'S' MINI-A | Jun 12, 1989 | Substantially Equivalent |
| K890509 | INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM | Mar 24, 1989 | Substantially Equivalent |
| K884595 | OPHTHASCAN MINI-B | Jan 3, 1989 | Substantially Equivalent |
| K884456 | STERILE DISPOSABLE ENDOCULAR PROBE | Dec 9, 1988 | Substantially Equivalent |
| K883719 | INTERCONN. OF OPHTHALAS & NANOLAS LASER SYSTEM | Oct 18, 1988 | Substantially Equivalent |
| K881494 | FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER | Aug 30, 1988 | Substantially Equivalent for Some Indications |
| K881459 | NANOLAS ND:YAG OPHTHALMIC LASER | Apr 13, 1988 | Substantially Equivalent |
| K873460 | OPHTHALAS DYE OPHTHALMIC LASER | Oct 29, 1987 | Substantially Equivalent |
| K844686 | OPHTHASCAN B | Sep 13, 1985 | Substantially Equivalent |