FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONVERTER SYSTEM
K Number: K894248
·
Decision Feb 27, 1990
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
148
Applicant Total
21
Review Days
251
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Basic Information
- Device Name
- CONVERTER SYSTEM
- K Number
- K894248
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4150
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Mira, Inc.
- Date Received
- June 21, 1989
- Decision Date
- February 27, 1990
- Product Code
- HQE
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | FDA class 2 | Ophthalmic |
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Other Clearances by Mira, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K951728 | SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE | Mar 19, 1997 | Substantially Equivalent |
| K950806 | SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS | Jun 5, 1996 | Substantially Equivalent |
| K941495 | RETURN PATH DIATHERMY HANDLE | Jul 15, 1994 | Substantially Equivalent |
| K933527 | MODIFICATION OF ANTERIOR SEGMENT ELECTRODES | Jan 25, 1994 | Substantially Equivalent |
| K923629 | OPHTHALMIC TRICHIASIS PROBE | Oct 19, 1992 | Substantially Equivalent |
| K891601 | POWER OPERATED AND CONTROLLED VITREOUS SCISSORS | May 23, 1989 | Substantially Equivalent |
| K890448 | LIGHT SOURCE, ENDOSCOP, XENON ARC | May 8, 1989 | Substantially Equivalent |
| K863246 | MIRALITE | Oct 31, 1986 | Substantially Equivalent |
| K863591 | ENDOPHOTOCOAGULATION PROBE | Oct 10, 1986 | Substantially Equivalent |
| K855105 | SIMMONS SHELL | Mar 31, 1986 | Substantially Equivalent |