Marco H and TS-1 Instrument Tables
FDA 510(k) K930447 · Marco Ophthalmic, Inc.
510(k) numberK930447
Submission
- Device name
- Marco H and TS-1 Instrument Tables
- 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
- HRJ – Table, Instrument, Powered, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4855
- Specialty
- Ophthalmic
Other 510(k)s with product code HRJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K922242 | 910T Montorized Instrument TableHRJ · Traditional | R.H. Burton Co. | 09/30/1992SE |
| K912134 | TBD, Lens Measuring DeviceHRJ · Traditional | Alcon Laboratories | 07/25/1991SE |
| K853744 | Techna Vision, Inc.Electric TableHRJ · Traditional | Techna Vision | 10/17/1985SE |
| K853359 | Reliance 1379HRJ · Traditional | Dentsply Intl. | 09/24/1985SE |
| K841760 | Woodlyn Classic Instrument StandHRJ · Traditional | Woodlyn, Inc. | 06/19/1984SE |
| K833820 | Machemer/Tano RotatingHRJ · Traditional | Optical Micro Systems, Inc. | 01/04/1984SE |
More from Optical Micro Systems, 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 |
| 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 H and TS-1 Instrument Tables cleared by the FDA?
Marco H and TS-1 Instrument Tables (K930447) 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 K930447?
The FDA product code is HRJ – Table, Instrument, Powered, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4855.