R&D Batteries # 5615, 5234, 5097
FDA 510(k) K935988 · R & D Batteries, Inc.
510(k) numberK935988
Submission
- Device name
- R&D Batteries # 5615, 5234, 5097
- Applicant
- R & D Batteries, Inc.
Burnsville, MN, US - Received
- December 14, 1993
- Decision date
- February 22, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HLI – Ophthalmoscope, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1570
- Specialty
- Ophthalmic
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| K142953 | OCT-CameraHLI · Traditional | Optomedical Technologies GmbH | 03/04/2015SE |
| K141638 | Propper Insight Binocular Indirect OphthalmosopeHLI · Abbreviated | Propper Manufacturing Co., Inc. | 09/17/2014SE |
| K133758 | Centervue Macular Integrity AssessmentHLI · Traditional | Centervue S.P.A. | 04/23/2014SE |
| K131939 | Amico DH-W35 Ophthalmoscope SeriesHLI · Traditional | Amico Diagnostic Incorporated | 03/26/2014SE |
| K133892 | Ivue 500HLI · Traditional | Optovue, Inc. | 03/19/2014SE |
| K123316 | Heine Omega 500HLI · Abbreviated | Heine Optotechnik GmbH & Co. KG | 02/26/2013SE |
| K121739 | Ivue with Normative DatabaseHLI · Traditional | Optovue, Inc. | 01/18/2013SE |
| K120057 | Envisu Spectral Domain Ophthalmic Imaging System (Sdois)HLI · Traditional | Bioptigen, Inc. | 05/11/2012SE |
More from Bioptigen, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K141795 | Batter Pack, Replacement for Physio Control Lifepak 500MKJ · Traditional | 12/08/2014SE |
| K951404 | R&D Batteries Part Nos. 5096, 5115, 5128 and 5131FLL · Traditional | 08/18/1995SE |
| K951403 | R&D Batteries Part Nos. 5164, 5252, 5634 and 5650FLL · Traditional | 08/18/1995SE |
| K951402 | R&D Batteries Part Nos. 5167, 5221, 5244 and 5247FLL · Traditional | 08/18/1995SE |
| K951401 | R&D Batteries Part Nos. 5015, 5016, 5037 and 5051FLL · Traditional | 08/18/1995SE |
| K951400 | R&D Batteries Part Nos. 5064, 5157, 5489 and 5536FLL · Traditional | 08/18/1995SE |
| K951399 | R&D Batteries Part Nos. 5041 & 5655FLL · Traditional | 08/18/1995SE |
| K951285 | R&D Batteries, Inc. Part Numbers 5158, 5168, 5171 and 5172FLL · Traditional | 08/18/1995SE |
| K951284 | R&D Batteries, Inc. Part Numbers 5137, 5140, 5142 and 5155FLL · Traditional | 08/18/1995SE |
| K951283 | R&D Batteries, Inc. Part Numbers 5075-B, 5076, 5122 and 5123FLL · Traditional | 08/18/1995SE |
Questions and answers
When was R&D Batteries # 5615, 5234, 5097 cleared by the FDA?
R&D Batteries # 5615, 5234, 5097 (K935988) received a 510(k) decision of Substantially Equivalent on February 22, 1994, 70 days after the submission was received.
What is the product code of K935988?
The FDA product code is HLI – Ophthalmoscope, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1570.