Nagashima Ns-Iii Electronystagmograph
FDA 510(k) K822268 · Kelleher Corp.
510(k) numberK822268
Submission
- Device name
- Nagashima Ns-Iii Electronystagmograph
- Applicant
- Kelleher Corp.
Mchenry, IL, US - Received
- July 29, 1982
- Decision date
- January 28, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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More from Dizzydoctor Systems, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K822618 | Emergency Tracheostomy Instrument SetLJW · Traditional | 01/28/1983SE |
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| K823111 | Nystymograph AccessGNN · Traditional | 11/22/1982SE |
| K822252 | ENT Treatment UnitsETF · Traditional | 11/22/1982SE |
| K822272 | Head Mirrors W/Head Lamps & Head BandsHPQ · Traditional | 11/10/1982SE |
| K822017 | Tympanostomy Tubes & Various TypesETD · Traditional | 10/27/1982SE |
| K822257 | Various Types of Light Source HandlesEOQ · Traditional | 10/26/1982SE |
| K822259 | Laryngeal SpatulasEQH · Traditional | 10/22/1982SE |
| K822004 | Face ShieldsKNT · Traditional | 10/20/1982SE |
| K822185 | Laryngeal SyringeFMF · Traditional | 10/18/1982SE |
Questions and answers
When was Nagashima Ns-Iii Electronystagmograph cleared by the FDA?
Nagashima Ns-Iii Electronystagmograph (K822268) received a 510(k) decision of Substantially Equivalent on January 28, 1983, 183 days after the submission was received.
What is the product code of K822268?
The FDA product code is GWN – Nystagmograph, a Class II (moderate risk) device regulated under 21 CFR 882.1460.