Projector, Accu-Chart Acuity
FDA 510(k) K781658 · Bausch & Lomb, Inc.
510(k) numberK781658
Submission
- Device name
- Projector, Accu-Chart Acuity
- Applicant
- Bausch & Lomb, Inc.
Mchenry, IL, US - Received
- September 28, 1978
- Decision date
- October 17, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K930443 | Marco CP-600 Auto Chart PROJECTOR/CP-1 Chart ProjeHOS · Traditional | Marco Ophthalmic, Inc. | 07/06/1993SE |
| 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 |
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Questions and answers
When was Projector, Accu-Chart Acuity cleared by the FDA?
Projector, Accu-Chart Acuity (K781658) received a 510(k) decision of Substantially Equivalent on October 17, 1978, 19 days after the submission was received.
What is the product code of K781658?
The FDA product code is HOS – Projector, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.1680.