Nagashima Light Source Unit SL-4
FDA 510(k) K821708 · Kelleher Corp.
510(k) numberK821708
Submission
- Device name
- Nagashima Light Source Unit SL-4
- Applicant
- Kelleher Corp.
Mchenry, IL, US - Received
- June 9, 1982
- Decision date
- June 25, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EQN – Laryngoscope, Nasopharyngoscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4760
- Specialty
- Ear, Nose, Throat
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code EQN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252624 | KARL STORZ Laryngoscopes and AccessoriesEQN · Traditional | KARL STORZ Endoscopy-America, Inc. | 05/15/2026SE |
| K150248 | ORL Video NasoPharyngo-LarngoscopeEQN · Traditional | Jedmed Instrument Company | 07/23/2015SE |
| K132039 | Ergo-Flex Laryngo-Nasopharyngoscope Ef-N and Ef-N SlimEQN · Traditional | Jedmed Instrument Co. | 02/21/2014SE |
| K834172 | Op-Con Surg. Instrument #7EQN · Traditional | Imm Enterprises , Ltd. | 03/06/1984SE |
| K831255 | Laryngoscope Attachment PH2000EQN · Traditional | Eder Instrument Co, Inc. | 09/12/1983SE |
| K830888 | Cool-Lite Fibercoptic Laryngeal ExamEQN · Traditional | National Medical Technology | 04/27/1983SE |
| K822525 | Laryngoscopes RigidEQN · Traditional | Kelleher Corp. | 09/09/1982SE |
| K821710 | Nagashima NX-150F Light Source UnitEQN · Traditional | Kelleher Corp. | 06/25/1982SE |
| K821709 | Nagashima Light Source Unit SL-5EQN · Traditional | Kelleher Corp. | 06/25/1982SE |
| K821707 | Nagashima Sft-Ii Laryngoscope StraightEQN · Traditional | Kelleher Corp. | 06/25/1982SE |
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 |
| 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 Light Source Unit SL-4 cleared by the FDA?
Nagashima Light Source Unit SL-4 (K821708) received a 510(k) decision of Substantially Equivalent on June 25, 1982, 16 days after the submission was received.
What is the product code of K821708?
The FDA product code is EQN – Laryngoscope, Nasopharyngoscope, a Class II (moderate risk) device regulated under 21 CFR 874.4760.