P1808 Mobile C-Arm Image Intensifier
FDA 510(k) K827087 · Precise Optics
510(k) numberK827087
Submission
- Device name
- P1808 Mobile C-Arm Image Intensifier
- Applicant
- Precise Optics
Bay Shore, NY, US - Received
- January 22, 1982
- Decision date
- March 4, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
More from Precise Optics
| 510(k) | Device | Decision |
|---|---|---|
| K030061 | PS 3000 Digatal Photospot SystemOWB · Traditional | 04/07/2003SE |
| K935580 | PHF20 20 Mobile C-Arm Image IntensifierOXO · Traditional | 03/16/1994SE |
| K932878 | Precision Intra-Oral ScopesEIA · Traditional | 01/06/1994SE |
| K914084 | EndoscopesGCJ · Traditional | 01/22/1992SE |
| K914184 | P2020-8-0 Beam-Limiting DeviceKPW · Traditional | 11/27/1991SE |
| K911744 | Precision Optics Corporation LaparoscopeGCJ · Traditional | 07/26/1991SE |
| K903459 | Precision Optics Endoscope AdapterFET · Traditional | 10/26/1990SE |
| K903458 | Precision Optics Image CouplerFET · Traditional | 10/19/1990SE |
| K903457 | Precision Optics Image Beamsplitter (Coupler)FET · Traditional | 10/19/1990SE |
| K820178 | PI808 Mobile C-Arm Image IntensifierJAA · Traditional | 03/04/1982SE |
Questions and answers
When was P1808 Mobile C-Arm Image Intensifier cleared by the FDA?
P1808 Mobile C-Arm Image Intensifier (K827087) received a 510(k) decision of Substantially Equivalent on March 4, 1982, 41 days after the submission was received.