Jedmed Spectrum ENT Cabinet
FDA 510(k) K953457 · Jedmed Instrument Co.
510(k) numberK953457
Submission
- Device name
- Jedmed Spectrum ENT Cabinet
- Applicant
- Jedmed Instrument Co.
Saint Louis, MO, US - Received
- July 21, 1995
- Decision date
- August 11, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- ETF – Unit, Examining/Treatment, Ent
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.5300
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code ETF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K945395 | Premier Mirror WarmerETF · Traditional | Premier Dental Products Co. | 01/18/1995SE |
| K932470 | Langgasse 90ETF · Traditional | Happersberger Otopront GmbH | 08/25/1993SE |
| K911901 | Maxi Cabinet Optional Built in S6000 Light SourceETF · Traditional | Stortz | 07/26/1991SE |
| K910781 | #491 Power Otolaryngoly CH/#498 Proced CTR & AccesETF · Traditional | Midmark Corp. | 05/15/1991SE |
| K910243 | Mobile Treatment CartETF · Traditional | Jedmed Instrument Co. | 04/17/1991SE |
| K896298 | Jedmed S ChairETF · Traditional | Jedmed Instrument Co. | 01/26/1990SE |
| K896273 | Systema ENT CabinetETF · Traditional | Jedmed Instrument Co. | 01/26/1990SE |
| K881958 | Jedmed Maxim ENT CabinetETF · Traditional | Jedmed Instrument Co. | 07/15/1988SE |
| K860940 | Micromedics Sterile, Disposable ENT Exam KitETF · Traditional | Micromedics, Inc. | 05/02/1986SE |
| K855021 | Laryngeal Mirror Pre-WarmerETF · Traditional | Jedmed Instrument Co. | 03/20/1986SE |
More from Jedmed Instrument Co.
| 510(k) | Device | Decision |
|---|---|---|
| K150248 | ORL Video NasoPharyngo-LarngoscopeEQN · Traditional | 07/23/2015SE |
| 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 |
| 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 Jedmed Spectrum ENT Cabinet cleared by the FDA?
Jedmed Spectrum ENT Cabinet (K953457) received a 510(k) decision of Substantially Equivalent on August 11, 1995, 21 days after the submission was received.
What is the product code of K953457?
The FDA product code is ETF – Unit, Examining/Treatment, Ent, a Class I (low risk) device regulated under 21 CFR 874.5300.