Reliance 1000, Reliance 1500, Reliance 2000
FDA 510(k) K853149 · F. & F. Koenigkramer
510(k) numberK853149
Submission
- Device name
- Reliance 1000, Reliance 1500, Reliance 2000
- Applicant
- F. & F. Koenigkramer
Cincinnati, OH, US - Received
- July 29, 1985
- Decision date
- September 5, 1985
- 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 |
| K864574 | Mac 150E Opthalmic ChairHME · Traditional | Koken Mfg Company, Inc. | 12/15/1986SE |
| 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 |
More from F. & F. Koenigkramer
| 510(k) | Device | Decision |
|---|---|---|
| K860519 | Reliance Model 200 Podiatry ChairLGX · Traditional | 02/19/1986SE |
| K853151 | Reliance 5000HME · Traditional | 09/05/1985SE |
| K853150 | Reliance 6100HME · Traditional | 09/05/1985SE |
| K843046 | Reliance Treatment CabinetETF · Traditional | 09/27/1984SE |
| K834060 | Reliance Ophthalmic Slit Lamp R-083HQF · Traditional | 02/04/1984SE |
| K831568 | Reliance Tempo Ophth. Instr StandHHF · Traditional | 06/30/1983SE |
| K812544 | Reliance Ophthalmic Instrument ControlHMF · Traditional | 09/21/1981SE |
| K761147 | Reliance Mod-U-Line M-700FPO · Traditional | 01/28/1977SE |
Questions and answers
When was Reliance 1000, Reliance 1500, Reliance 2000 cleared by the FDA?
Reliance 1000, Reliance 1500, Reliance 2000 (K853149) received a 510(k) decision of Substantially Equivalent on September 5, 1985, 38 days after the submission was received.
What is the product code of K853149?
The FDA product code is HME – Chair, Ophthalmic, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.1140.