Acoustic Rhinometer
FDA 510(k) K921452 · Hood Laboratories
510(k) numberK921452
Submission
- Device name
- Acoustic Rhinometer
- Applicant
- Hood Laboratories
Pembroke, MA, US - Received
- March 26, 1992
- Decision date
- July 8, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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| 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 |
| K902120 | Mercury RhinomanometerBXQ · Traditional | Life-Tech Intl., Inc. | 08/06/1990SE |
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| K853024 | Rhinotest MPBXQ · Traditional | Intertronic, Inc. | 09/27/1985SE |
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More from And/Or Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K920994 | Hood Nasal Septal ButtonLFB · Traditional | 05/15/1992SE |
| K905703 | Krupin Eye Valve with DiskKYF · Traditional | 03/15/1991SE |
| K904821 | Eliachar Modified Esophageal StentESW · Traditional | 01/14/1991SE |
| K897049 | Gibson Endolymphatic ShuntESZ · Traditional | 03/16/1990SE |
| K897059 | Hood Speaking ValveJOH · Traditional | 03/12/1990SE |
| K893866 | Hood Pediatric Tracheostomy TubeBTO · Traditional | 08/07/1989SE |
| K884810 | Silicone Laryngeal StentFWN · Traditional | 05/10/1989SE |
| K890599 | Hood Nasal SplintEPP · Traditional | 03/17/1989SE |
| K885125 | Krupin Eye Valve W/Scleral BuckleKYF · Traditional | 01/24/1989SE |
| K882430 | Hood Tracheal Stoma ButtonBTO · Traditional | 06/28/1988SE |
Questions and answers
When was Acoustic Rhinometer cleared by the FDA?
Acoustic Rhinometer (K921452) received a 510(k) decision of Substantially Equivalent on July 8, 1993, 469 days after the submission was received.
What is the product code of K921452?
The FDA product code is BXQ – Rhinoanemometer (Measurement Of Nasal Decongestion), a Class II (moderate risk) device regulated under 21 CFR 868.1800.