FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLEXIBLE FIBER OPTIC ENDOSCOPE
K Number: K922937
·
Decision Sep 14, 1992
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
238
Applicant Total
15
Review Days
88
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Basic Information
- Device Name
- FLEXIBLE FIBER OPTIC ENDOSCOPE
- K Number
- K922937
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4680
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Optimed Technologies, Inc.
- Date Received
- June 18, 1992
- Decision Date
- September 14, 1992
- Product Code
- EOQ
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | FDA class 2 | Ear, Nose, Throat |
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EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)
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Other Clearances by Optimed Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972520 | OPTIVIEW | Sep 29, 1997 | Substantially Equivalent |
| K955275 | BOOSTER TROPHY 5 MOTORIZED SCOOTER | Nov 4, 1996 | Substantially Equivalent |
| K955276 | BOOSTER LITE 4 MOTORIZED SCOOTER | Nov 4, 1996 | Substantially Equivalent |
| K955274 | BOOSTER LITE 3 MOTORIZED SCOOTER | Nov 4, 1996 | Substantially Equivalent |
| K943598 | FLEXIBLE FIBER OPTIC LAPAROSCOPES | Oct 18, 1994 | Substantially Equivalent |
| K926597 | LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) | Jul 12, 1994 | Substantially Equivalent |
| K921942 | HYSTEROSCOPE (AND ACCESSORIES) | Jun 24, 1994 | Substantially Equivalent |
| K922711 | FLEXIBLE FIBER OPTIC GYNECOLOGIC ENDOSCOPE | May 17, 1994 | Substantially Equivalent |
| K921985 | ARTHROSCOPE & ACCESSORIES | Jun 29, 1993 | Substantially Equivalent |
| K922826 | FLEXIBLE FIBER OPTIC ENDOSCOPE | Feb 19, 1993 | Substantially Equivalent |