Marco GXX Series Photographic Slit Lamps
FDA 510(k) K930442 · Marco Ophthalmic, Inc.
510(k) numberK930442
Submission
- Device name
- Marco GXX Series Photographic Slit Lamps
- Applicant
- Marco Ophthalmic, Inc.
Jacksonville, FL, US - Received
- January 26, 1993
- Decision date
- August 9, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HKI – Camera, Ophthalmic, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1120
- Specialty
- Ophthalmic
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| 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 |
| K930441 | Marco Standard Lensmeters 101,201HLM · Traditional | 07/06/1993SE |
Questions and answers
When was Marco GXX Series Photographic Slit Lamps cleared by the FDA?
Marco GXX Series Photographic Slit Lamps (K930442) received a 510(k) decision of Substantially Equivalent on August 9, 1993, 195 days after the submission was received.
What is the product code of K930442?
The FDA product code is HKI – Camera, Ophthalmic, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1120.