Marco Projection Perimeter
FDA 510(k) K930448 · Marco Ophthalmic, Inc.
510(k) numberK930448
Submission
- Device name
- Marco Projection Perimeter
- Applicant
- Marco Ophthalmic, Inc.
Jacksonville, FL, US - Received
- January 26, 1993
- Decision date
- June 21, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HOO – Perimeter, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1605
- Specialty
- Ophthalmic
Other 510(k)s with product code HOO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K941723 | Welch Allyn Glaucoma DetectorHOO · Traditional | Welch Allyn, Inc. | 06/06/1994SE |
| K873912 | Richmond Visual Field ScreenerHOO · Traditional | Richmond Products, Inc. | 11/02/1987SE |
| K864467 | Henson - Hamblin CFS 2000 Central Field ScreenHOO · Traditional | Keeler Instruments, Inc. | 12/15/1986SE |
| K860115 | Digilab Cambridge PerimeterHOO · Traditional | Bio-Rad | 02/27/1986SE |
| K832800 | Automatic Tangent Screen 50HOO · Traditional | CooperVision, Inc. | 09/29/1983SE |
More from CooperVision, 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 |
| K930443 | Marco CP-600 Auto Chart PROJECTOR/CP-1 Chart ProjeHOS · Traditional | 07/06/1993SE |
Questions and answers
When was Marco Projection Perimeter cleared by the FDA?
Marco Projection Perimeter (K930448) received a 510(k) decision of Substantially Equivalent on June 21, 1993, 146 days after the submission was received.
What is the product code of K930448?
The FDA product code is HOO – Perimeter, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.1605.