H 5100, H 5200, H 5300
FDA 510(k) K945507 · Rudolf Riester GmbH & Co. KG
510(k) numberK945507
Submission
- Device name
- H 5100, H 5200, H 5300
- Applicant
- Rudolf Riester GmbH & Co. KG
D-72417 Jungingen, DE - Received
- November 9, 1994
- Decision date
- December 9, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KZF – Device, Medical Examination, Ac Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6320
- Specialty
- General Hospital
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| K936088 | Wave Fluorescent MagnifierKZF · Traditional | Burton Medical Products Corp. | 04/26/1994SE |
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| K935832 | ChromophareKZF · Traditional | Berchtold Holding GmbH | 02/03/1994SE |
| K934259 | Ac-Powered Medical Examination LightKZF · Traditional | Welch Allyn, Inc. | 01/28/1994SE |
| K932719 | Ritter Model 158 and 159 Exam LightsKZF · Traditional | Midmark Corp. | 12/02/1993SE |
| K924447 | VitapenKZF · Traditional | Vitajet Corp. | 09/27/1993SE |
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Questions and answers
When was H 5100, H 5200, H 5300 cleared by the FDA?
H 5100, H 5200, H 5300 (K945507) received a 510(k) decision of Substantially Equivalent on December 9, 1994, 30 days after the submission was received.
What is the product code of K945507?
The FDA product code is KZF – Device, Medical Examination, Ac Powered, a Class I (low risk) device regulated under 21 CFR 880.6320.