FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INFINITECH OTOPROBE
K Number: K931264
·
Decision Mar 1, 1994
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
6
Review Days
358
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Basic Information
- Device Name
- INFINITECH OTOPROBE
- K Number
- K931264
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Infinitech, Inc.
- Date Received
- March 8, 1993
- Decision Date
- March 1, 1994
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Infinitech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972506 | INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR | Oct 1, 1997 | Substantially Equivalent |
| K971950 | INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTER | Aug 1, 1997 | Substantially Equivalent |
| K951627 | INFINITECH HIGH INTENSITY XENON LIGHT SOURCE SYSTEM | Oct 19, 1995 | Substantially Equivalent |
| K931546 | END-IRRIGATING ENDOILLUMINATOR | Feb 9, 1994 | Substantially Equivalent |
| K935441 | INFINITECH BREATH EZ | Feb 7, 1994 | Substantially Equivalent |