Marco CP-600 Auto Chart PROJECTOR/CP-1 Chart Proje
FDA 510(k) K930443 · Marco Ophthalmic, Inc.
510(k) numberK930443
Submission
- Device name
- Marco CP-600 Auto Chart PROJECTOR/CP-1 Chart Proje
- Applicant
- Marco Ophthalmic, Inc.
Jacksonville, FL, US - Received
- January 26, 1993
- Decision date
- July 6, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HOS – Projector, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1680
- Specialty
- Ophthalmic
Other 510(k)s with product code HOS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K936200 | Wireless Chart Projector,Hcp-W 721HOS · Traditional | Canon USA, Inc. | 09/28/1994SE |
| K924784 | Burton Projector Head - Model 6000-HHOS · Traditional | R.H. Burton Co. | 04/05/1993SE |
| K921214 | Ophthalmic ProjectorHOS · Traditional | Luneau Ophtalmologie SA | 06/11/1992SE |
| K890992 | Woodlyn Ophthalmic ProjectorHOS · Traditional | Woodlyn, Inc. | 05/17/1989SE |
| K862519 | Bausch & Lomb Accu-Chart 3 Acuity ProjectorHOS · Traditional | Bausch & Lomb, Inc. | 07/23/1986SE |
| K812706 | Miller/Nadler Glare TesterHOS · Traditional | Mosebach Electric & Supply | 11/16/1981SE |
| K811180 | Ultramatic Project-O-Chart Ophth. ProjHOS · Traditional | American Optical Corp. | 05/15/1981SE |
| K781658 | Projector, Accu-Chart AcuityHOS · Traditional | Bausch & Lomb, Inc. | 10/17/1978SE |
More from Bausch & Lomb, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K943234 | MS-30 Automatic PerimeterHPT · Traditional | 07/27/1994SE |
| K930444 | Marco Standard KeratometersHJB · Traditional | 08/09/1993SE |
| K930442 | Marco GXX Series Photographic Slit LampsHKI · Traditional | 08/09/1993SE |
| K930438 | Marco Models G,H and Primary Care Slit LampsHJO · Traditional | 08/09/1993SE |
| K930437 | Marco Standard RadiusgaugesHLF · Traditional | 08/09/1993SE |
| K930439 | Marco Surgiscope Operation MicroscopesHRM · Traditional | 07/22/1993SE |
| K930449 | Marco, Marcotilt, Encore and Custom ChairHME · Traditional | 07/06/1993SE |
| K930447 | Marco H and TS-1 Instrument TablesHRJ · Traditional | 07/06/1993SE |
| K930446 | Marco Trial SetsHPC · Traditional | 07/06/1993SE |
| K930441 | Marco Standard Lensmeters 101,201HLM · Traditional | 07/06/1993SE |
Questions and answers
When was Marco CP-600 Auto Chart PROJECTOR/CP-1 Chart Proje cleared by the FDA?
Marco CP-600 Auto Chart PROJECTOR/CP-1 Chart Proje (K930443) received a 510(k) decision of Substantially Equivalent on July 6, 1993, 161 days after the submission was received.
What is the product code of K930443?
The FDA product code is HOS – Projector, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.1680.