FDA 510(k)
Substantially Equivalent
🇺🇸 United States
OMS CRYO
K Number: K844467
·
Decision Feb 22, 1985
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
21
Review Days
95
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- OMS CRYO
- K Number
- K844467
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Optical Micro Systems, Inc.
- Date Received
- November 19, 1984
- Decision Date
- February 22, 1985
- Advisory Committee
- Unknown
- Review Advisory Committee
- DE
- Third Party
- N
Other Clearances by Optical Micro Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K950218 | OMS SLIMLINE PHACO HANDPIECE | Jul 17, 1995 | Substantially Equivalent |
| K946054 | DIPLOMAX | Jul 11, 1995 | Substantially Equivalent |
| K935223 | OPHTHALMIC SURGICAL SYSTEM | Mar 14, 1994 | Substantially Equivalent |
| K935226 | I/V POLE | Feb 16, 1994 | Substantially Equivalent |
| K935003 | ELECTRIC I/V POLE OR EIVP2 | Jan 25, 1994 | Substantially Equivalent |
| K870068 | ASPIRATION REVERSAL CONTROL (ARC) MODULE | Feb 12, 1987 | Substantially Equivalent |
| K844373 | O.M.S. ULTRA-PHACO | Dec 19, 1985 | Substantially Equivalent |
| K844448 | OMS/GONVERS RETINAL PERFORATOR | Aug 21, 1985 | Substantially Equivalent |
| K844895 | OMS SILICONE OIL INJECTOR | Jun 24, 1985 | Substantially Equivalent |
| K844715 | VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SY | Jan 22, 1985 | Substantially Equivalent |