Mac 150E Opthalmic Chair
FDA 510(k) K864574 · Koken Mfg Company, Inc.
510(k) numberK864574
Submission
- Device name
- Mac 150E Opthalmic Chair
- Applicant
- Koken Mfg Company, Inc.
St. Louis, MO, US - Received
- November 20, 1986
- Decision date
- December 15, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HME – Chair, Ophthalmic, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1140
- Specialty
- Ophthalmic
Other 510(k)s with product code HME
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K930449 | Marco, Marcotilt, Encore and Custom ChairHME · Traditional | Marco Ophthalmic, Inc. | 07/06/1993SE |
| K914416 | Breath-Easy, ModificationHME · Traditional | Icor AB | 06/23/1992SE |
| K894018 | Reliance(R) 6200 Examination ChairHME · Traditional | Reliance Medical Products, Inc. | 09/12/1989SE |
| K870112 | Storz Ent/Ophthalmic Maxi ChairHME · Traditional | Storz Instrument Co. | 02/12/1987SE |
| K864494 | Model 6500 Opthalmic ChairHME · Traditional | Koken Mfg Company, Inc. | 12/15/1986SE |
| K863728 | The Ergosystem ChairHME · Traditional | Charles D. Bell, Inc. | 10/31/1986SE |
| K863008 | -Om West 2000 Gnatus ChairHME · Traditional | Sds Dental, Inc. | 09/24/1986SE |
| K853743 | Techna Vision, Inc. Electric ChairHME · Traditional | Techna Vision | 10/17/1985SE |
| K853151 | Reliance 5000HME · Traditional | F. & F. Koenigkramer | 09/05/1985SE |
| K853150 | Reliance 6100HME · Traditional | F. & F. Koenigkramer | 09/05/1985SE |
More from F. & F. Koenigkramer
Questions and answers
When was Mac 150E Opthalmic Chair cleared by the FDA?
Mac 150E Opthalmic Chair (K864574) received a 510(k) decision of Substantially Equivalent on December 15, 1986, 25 days after the submission was received.
What is the product code of K864574?
The FDA product code is HME – Chair, Ophthalmic, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.1140.