R and D Batteries, Inc. Part Nos. 5038 & 5347
FDA 510(k) K933491 · R & D Batteries, Inc.
510(k) numberK933491
Submission
- Device name
- R and D Batteries, Inc. Part Nos. 5038 & 5347
- Applicant
- R & D Batteries, Inc.
Burnsville, MN, US - Received
- July 15, 1993
- Decision date
- November 19, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- ETN – Stimulator, Nerve
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.1820
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code ETN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253536 | Evala Nerve Stimulator (EPNR002)ETN · Traditional | Epineuron Technologies, Inc. | 02/27/2026SE |
| K251672 | NIM Essence EMG Endotracheal Tube (NIMEID060); NIM Essence EMG Endotracheal Tube…ETN · Traditional | Medtronic Xomed, Inc. | 02/10/2026SE |
| K242852 | ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube…ETN · Traditional | Inomed Medizintechnik GmbH | 06/13/2025SE |
| K233001 | Bioscope Neuromonitor DeviceETN · Traditional | Biosys Biyomedikal Muhendislik San. VE Tic. A.S. | 12/13/2024SE |
| K241917 | EARP Nerve Cuff ElectrodeETN · Special | Retropsoas Technologies, LLC | 07/31/2024SE |
| K232888 | Disposable Laryngeal ElectrodesETN · Traditional | Suzhou Haishen Medical Device Associates Co., Ltd. | 12/21/2023SE |
| K230320 | NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal TubeETN · Special | Medtronic Xomed, Inc. | 10/26/2023SE |
| K230853 | EARP Nerve Cuff ElectrodeETN · Traditional | Nvision Biomedical Technologies, Inc. | 10/06/2023SE |
| K231580 | NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)ETN · Traditional | Medtronic Xomed, Inc. | 08/30/2023SE |
| K223254 | C2 XploreETN · Traditional | Inomed Medizintechnik GmbH | 01/27/2023SE |
More from Inomed Medizintechnik GmbH
| 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 and D Batteries, Inc. Part Nos. 5038 & 5347 cleared by the FDA?
R and D Batteries, Inc. Part Nos. 5038 & 5347 (K933491) received a 510(k) decision of Substantially Equivalent on November 19, 1993, 127 days after the submission was received.
What is the product code of K933491?
The FDA product code is ETN – Stimulator, Nerve, a Class II (moderate risk) device regulated under 21 CFR 874.1820.