Binocular Operating Microscopes &
FDA 510(k) K822012 · Kelleher Corp.
510(k) numberK822012
Submission
- Device name
- Binocular Operating Microscopes &
- Applicant
- Kelleher Corp.
Mchenry, IL, US - Received
- July 8, 1982
- Decision date
- July 30, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code HBN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K900472 | Skytron Model 860 and 800 Comp. Surgita Neuro EquiHBN · Traditional | Skytron, Div. the Kmw Group, Inc. | 09/04/1990SE |
| K822428 | Surgi-Quip Microscope StandHBN · Traditional | Surgi-Quip Inc.U | 09/02/1982SE |
| K822426 | Mcintyre Microscope StandHBN · Traditional | Surgi-Quip Inc.U | 09/02/1982SE |
More from Surgi-Quip Inc.U
| 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 Binocular Operating Microscopes & cleared by the FDA?
Binocular Operating Microscopes & (K822012) received a 510(k) decision of Substantially Equivalent on July 30, 1982, 22 days after the submission was received.
What is the product code of K822012?
The FDA product code is HBN – Chair, Neurosurgical, a Class I (low risk) device regulated under 21 CFR 882.4125.