FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRECISION OPTICS IMAGE COUPLER
K Number: K903458
·
Decision Oct 19, 1990
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
97
Applicant Total
13
Review Days
79
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Basic Information
- Device Name
- PRECISION OPTICS IMAGE COUPLER
- K Number
- K903458
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Precise Optics
- Date Received
- August 1, 1990
- Decision Date
- October 19, 1990
- Product Code
- FET
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Precise Optics
| K Number | Device Name | ||
|---|---|---|---|
| K030061 | PS 3000 DIGATAL PHOTOSPOT SYSTEM | Apr 7, 2003 | Substantially Equivalent |
| K935580 | PHF20 20 MOBILE C-ARM IMAGE INTENSIFIER | Mar 16, 1994 | Substantially Equivalent |
| K932878 | PRECISION INTRA-ORAL SCOPES | Jan 6, 1994 | Substantially Equivalent |
| K914084 | ENDOSCOPES | Jan 22, 1992 | Substantially Equivalent |
| K914184 | P2020-8-0 BEAM-LIMITING DEVICE | Nov 27, 1991 | Substantially Equivalent |
| K911744 | PRECISION OPTICS CORPORATION LAPAROSCOPE | Jul 26, 1991 | Substantially Equivalent |
| K903459 | PRECISION OPTICS ENDOSCOPE ADAPTER | Oct 26, 1990 | Substantially Equivalent |
| K903457 | PRECISION OPTICS IMAGE BEAMSPLITTER (COUPLER) | Oct 19, 1990 | Substantially Equivalent |
| K820178 | PI808 MOBILE C-ARM IMAGE INTENSIFIER | Mar 4, 1982 | Substantially Equivalent |
| K827087 | P1808 MOBILE C-ARM IMAGE INTENSIFIER | Mar 4, 1982 | Substantially Equivalent |