ORL Video NasoPharyngo-Larngoscope
FDA 510(k) K150248 · Jedmed Instrument Company
510(k) numberK150248
Submission
- Device name
- ORL Video NasoPharyngo-Larngoscope
- Applicant
- Jedmed Instrument Company
Saint Louis, MO, US - Received
- February 3, 2015
- Decision date
- July 23, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K821708 | Nagashima Light Source Unit SL-4EQN · 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 |
|---|---|---|
| K132039 | Ergo-Flex Laryngo-Nasopharyngoscope Ef-N and Ef-N SlimEQN · Traditional | 02/21/2014SE |
| K021750 | Lid Chain Eyelid WeightsMML · Traditional | 01/27/2003SE |
| K954184 | Jed-Light Fiberoptic Light SourceEQH · Traditional | 11/13/1995SE |
| K944032 | Video Scope System (Laryngoscope)ENZ · Traditional | 09/15/1995SE |
| K953457 | Jedmed Spectrum ENT CabinetETF · Traditional | 08/11/1995SE |
| K950925 | Jedmed Laryngeal ScopeEOQ · Traditional | 08/11/1995SE |
| K950785 | Hortmann Airmatic Air Caloric StimulatorKHH · Traditional | 06/28/1995SE |
| K950078 | Microflow Irrigation SystemKMA · Traditional | 06/21/1995SE |
| K944671 | Video Scope System (Nasopharyngoscope {Flexible or Rigid})EOB · Traditional | 02/07/1995SE |
| K944031 | Video Scope System (Otoscope)ERA · Traditional | 09/23/1994SE |
Questions and answers
When was ORL Video NasoPharyngo-Larngoscope cleared by the FDA?
ORL Video NasoPharyngo-Larngoscope (K150248) received a 510(k) decision of Substantially Equivalent on July 23, 2015, 170 days after the submission was received.
What is the product code of K150248?
The FDA product code is EQN – Laryngoscope, Nasopharyngoscope, a Class II (moderate risk) device regulated under 21 CFR 874.4760.