Precise Optics
Stamford, CT, US
Precise Optics appears in FDA device records in Stamford, CT. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Precise Optics between 1979 and 2003. The busiest year on record is 1990, with 3. The most recent is 2003, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1980 | 1 |
| 1982 | 2 |
| 1990 | 3 |
| 1991 | 2 |
| 1992 | 1 |
| 1994 | 2 |
| 2003 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K030061 | PS 3000 DIGATAL PHOTOSPOT SYSTEM | OWB | Substantially Equivalent | |
| K935580 | PHF20 20 MOBILE C-ARM IMAGE INTENSIFIER | OXO | Substantially Equivalent | |
| K932878 | PRECISION INTRA-ORAL SCOPES | EIA | Substantially Equivalent | |
| K914084 | ENDOSCOPES | GCJ | Substantially Equivalent | |
| K914184 | P2020-8-0 BEAM-LIMITING DEVICE | KPW | Substantially Equivalent | |
| K911744 | PRECISION OPTICS CORPORATION LAPAROSCOPE | GCJ | Substantially Equivalent | |
| K903459 | PRECISION OPTICS ENDOSCOPE ADAPTER | FET | Substantially Equivalent | |
| K903458 | PRECISION OPTICS IMAGE COUPLER | FET | Substantially Equivalent | |
| K903457 | PRECISION OPTICS IMAGE BEAMSPLITTER (COUPLER) | FET | Substantially Equivalent | |
| K827087 | P1808 MOBILE C-ARM IMAGE INTENSIFIER | Substantially Equivalent | ||
| K820178 | PI808 MOBILE C-ARM IMAGE INTENSIFIER | JAA | Substantially Equivalent | |
| K792307 | DENTIX DENTAL X-RAY UNIT | EAP | Substantially Equivalent | |
| K792225 | P1806 MOBILE C-ARM IMAGE INTENSIFIER | JAA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KPWDevice, Beam Limiting, X-Ray, Diagnostic
- FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
- OXOImage-Intensified Fluoroscopic X-Ray System, Mobile
- OWBInterventional Fluoroscopic X-Ray System
- GCJLaparoscope, General & Plastic Surgery
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- EIAUnit, Operative Dental
- EAPUnit, X-Ray, Intraoral
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain