Nagashima SN Operator's Chair
FDA 510(k) K822264 · Kelleher Corp.
510(k) numberK822264
Submission
- Device name
- Nagashima SN Operator's Chair
- Applicant
- Kelleher Corp.
Walker, MI, US - Received
- July 29, 1982
- Decision date
- October 13, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GBB – Chair, Surgical, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4960
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GBB
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|---|---|---|---|
| K964102 | Tenet Tibial Fracture SupportGBB · Traditional | Tenet Medical Engineering | 12/05/1996SE |
| K893598 | Hydraulic Foot Operated StoolGBB · Traditional | Arthro-Medic, Inc. | 10/10/1989SE |
| K831385 | Lithotomy Chair #415GBB · Traditional | Midmark Corp. | 06/02/1983SE |
| K831325 | NutromatGBB · Traditional | Medlog GmbH Marketing Services | 06/02/1983SE |
| K822251 | Examination & Treatment ChairsGBB · Traditional | Kelleher Corp. | 08/27/1982SE |
| K822013 | Nagashima SN Automatic Treatment ChairGBB · Traditional | Kelleher Corp. | 07/28/1982SE |
| K820636 | Storz #6500 Power Examination ChairGBB · Traditional | Storz Instrument Co. | 03/26/1982SE |
More from Storz Instrument Co.
| 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 |
| 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 |
Questions and answers
When was Nagashima SN Operator's Chair cleared by the FDA?
Nagashima SN Operator's Chair (K822264) received a 510(k) decision of Substantially Equivalent on October 13, 1982, 76 days after the submission was received.
What is the product code of K822264?
The FDA product code is GBB – Chair, Surgical, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 878.4960.