Rhinomanometer
FDA 510(k) K896263 · Jedmed Instrument Co.
510(k) numberK896263
Submission
- Device name
- Rhinomanometer
- Applicant
- Jedmed Instrument Co.
St. Louis, MO, US - Received
- October 31, 1989
- Decision date
- April 16, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BXQ – Rhinoanemometer (Measurement Of Nasal Decongestion)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1800
- Specialty
- Anesthesiology
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|---|---|---|---|
| K221892 | VisionairBXQ · Traditional | Pacificmd Biotech, LLC | 10/05/2022SE |
| K170071 | SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM…BXQ · Traditional | Sleep Group Solutions | 11/09/2017SE |
| K022311 | Rhinostream Rhinomanometer ModuleBXQ · Traditional | Rhino Metrics A/S | 10/04/2002SE |
| K011329 | Eccovision Acoustic Diagnostic Imaging Acoustic PharyngometerBXQ · Traditional | E. Benson Hood Lab, Inc. | 07/26/2002SE |
| K000406 | Rhinoscan Model SRE2000/ SRE2100 with Acoustic Rhinometry ModuleBXQ · Traditional | Rhino Metrics A/S | 04/17/2000SE |
| K972140 | A1 Acoustic RhinometerBXQ · Traditional | G.M. Instruments , Ltd. | 09/30/1998SE |
| K921452 | Acoustic RhinometerBXQ · Traditional | Hood Laboratories | 07/08/1993SE |
| K902120 | Mercury RhinomanometerBXQ · Traditional | Life-Tech Intl., Inc. | 08/06/1990SE |
| K853024 | Rhinotest MPBXQ · Traditional | Intertronic, Inc. | 09/27/1985SE |
| K851143 | Rhinomanometers NR3, NR4BXQ · Traditional | And/Or Corp. | 05/23/1985SE |
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| 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 |
| 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 |
Questions and answers
When was Rhinomanometer cleared by the FDA?
Rhinomanometer (K896263) received a 510(k) decision of Substantially Equivalent on April 16, 1990, 167 days after the submission was received.
What is the product code of K896263?
The FDA product code is BXQ – Rhinoanemometer (Measurement Of Nasal Decongestion), a Class II (moderate risk) device regulated under 21 CFR 868.1800.