Ri-Former Wall Model 2,5 V/220 V or 110 V 3,5 V/220 V or 110 V, Ri-Former Anaesthetic Model 2,5 V/220 V or 110 C 3,5 V/V
FDA 510(k) K950914 · Rudolf Riester GmbH & Co. KG
510(k) numberK950914
Submission
- Device name
- Ri-Former Wall Model 2,5 V/220 V or 110 V 3,5 V/220 V or 110 V, Ri-Former Anaesthetic Model 2,5 V/220 V or 110 C 3,5 V/V
- Applicant
- Rudolf Riester GmbH & Co. KG
D-72417 Jungingen, DE - Received
- February 23, 1995
- Decision date
- July 24, 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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| K131959 | Heine Mini 3000(R) OphthalmoscopeHLJ · Abbreviated | Heine Optotechnik GmbH & Co. KG | 03/07/2014SE |
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| 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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Questions and answers
When was Ri-Former Wall Model 2,5 V/220 V or 110 V 3,5 V/220 V or 110 V, Ri-Former Anaesthetic Model 2,5 V/220 V or 110 C 3,5 V/V cleared by the FDA?
Ri-Former Wall Model 2,5 V/220 V or 110 V 3,5 V/220 V or 110 V, Ri-Former Anaesthetic Model 2,5 V/220 V or 110 C 3,5 V/V (K950914) received a 510(k) decision of Substantially Equivalent on July 24, 1995, 151 days after the submission was received.
What is the product code of K950914?
The FDA product code is HLJ – Ophthalmoscope, Battery-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1570.