Nystymograph Access
FDA 510(k) K823111 · Kelleher Corp.
510(k) numberK823111
Submission
- Device name
- Nystymograph Access
- Applicant
- Kelleher Corp.
Mchenry, IL, US - Received
- October 25, 1982
- Decision date
- November 22, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GNN – Antisera, Neutralization, Coxsackievirus A 1-24, B 1-6
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3145
- Specialty
- Microbiology
More from Kelleher Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K822618 | Emergency Tracheostomy Instrument SetLJW · Traditional | 01/28/1983SE |
| K822268 | Nagashima Ns-Iii ElectronystagmographGWN · Traditional | 01/28/1983SE |
| K823083 | Electrosurgical UnitGEI · Traditional | 12/07/1982SE |
| 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 Nystymograph Access cleared by the FDA?
Nystymograph Access (K823111) received a 510(k) decision of Substantially Equivalent on November 22, 1982, 28 days after the submission was received.
What is the product code of K823111?
The FDA product code is GNN – Antisera, Neutralization, Coxsackievirus A 1-24, B 1-6, a Class I (low risk) device regulated under 21 CFR 866.3145.