Halogen Ophthalmo-Otoscope Set BX a - 134
FDA 510(k) K950797 · Neitz Instruments Company, Ltd.
510(k) numberK950797
Submission
- Device name
- Halogen Ophthalmo-Otoscope Set BX a - 134
- Applicant
- Neitz Instruments Company, Ltd.
Tokyo, JP - Received
- February 21, 1995
- Decision date
- March 28, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HLJ – Ophthalmoscope, Battery-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1570
- Specialty
- Ophthalmic
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| K142486 | Heine Beta 200, Heine Beta 200 S, Heine K 180HLJ · Abbreviated | Heine Optotechnik GmbH & Co. KG | 05/18/2015SE |
| K142837 | Heine Sigma 250 & Heine Sigma 250 M2HLJ · Abbreviated | Heine Optotechnik GmbH & Co. KG | 01/29/2015SE |
| K131959 | Heine Mini 3000(R) OphthalmoscopeHLJ · Abbreviated | Heine Optotechnik GmbH & Co. KG | 03/07/2014SE |
| K131961 | Heine Beta 200(R) OphthalmoscopeHLJ · Abbreviated | Heine Optotechnik GmbH & Co. KG | 12/04/2013SE |
| K131719 | Ophthalmoscopes Diagnostic Instrument KitsHLJ · Traditional | Medical Devices (Pvt) , Ltd. | 10/30/2013SE |
| K123587 | Heine Mini 3000 LED OphthalmoscopeHLJ · Abbreviated | Heine Optotechnik GmbH & Co. KG | 03/22/2013SE |
| K093495 | Otoscope and Ophthalmoscope Diagnostic Instrument KitsHLJ · Traditional | American Diagnostic Corp. | 11/19/2010SE |
| K070270 | Piccolight E50,PICCOLIGHT E56,EUROLIGHT E10, Eurolight E30, and Eurolight E36HLJ · Traditional | Kirchner & Wilhelm GmbH + Co.Kg | 11/05/2007SE |
| K052599 | 66 Vision Tech Ophthalmoscope, Models YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25AHLJ · Traditional | Suzhou 66 Vision Tech Co., Ltd. | 11/07/2006SE |
| K061278 | Optyse OphthalmoscopeHLJ · Abbreviated | Ophthalmos , Ltd. | 05/16/2006SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K972440 | Cataractscreener CT - SHKI · Traditional | 09/30/1997SE |
| K951341 | Neitz Slit Lamp SL-H2HJO · Traditional | 06/15/1995SE |
| K951337 | Fiber Head Light FH-300HPQ · Traditional | 06/08/1995SE |
| K950788 | Otoscope A-34ERA · Traditional | 05/03/1995SE |
| K951340 | Neitz Slit Lamp SL-H1HJO · Traditional | 04/10/1995SE |
| K951338 | Indirect Ophthalmoscope Video System IO0 a TVHLI · Traditional | 04/07/1995SE |
| K950795 | Streak Retinoscope Rx-RpHKM · Traditional | 03/28/1995SE |
| K950794 | Streak Retinoscope Rx-RcHKM · Traditional | 03/28/1995SE |
| K950793 | Spot Retinoscope RX-3SPHKM · Traditional | 03/28/1995SE |
| K950792 | Streak Retinoscope RX-3AHKM · Traditional | 03/28/1995SE |
Questions and answers
When was Halogen Ophthalmo-Otoscope Set BX a - 134 cleared by the FDA?
Halogen Ophthalmo-Otoscope Set BX a - 134 (K950797) received a 510(k) decision of Substantially Equivalent on March 28, 1995, 35 days after the submission was received.
What is the product code of K950797?
The FDA product code is HLJ – Ophthalmoscope, Battery-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1570.