Rhinoscan Model SRE2000/ SRE2100 with Acoustic Rhinometry Module
FDA 510(k) K000406 · Rhino Metrics A/S
510(k) numberK000406
Submission
- Device name
- Rhinoscan Model SRE2000/ SRE2100 with Acoustic Rhinometry Module
- Applicant
- Rhino Metrics A/S
Washington, DC, US - Received
- February 7, 2000
- Decision date
- April 17, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| K921452 | Acoustic RhinometerBXQ · Traditional | Hood Laboratories | 07/08/1993SE |
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More from And/Or Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K022311 | Rhinostream Rhinomanometer ModuleBXQ · Traditional | 10/04/2002SE |
Questions and answers
When was Rhinoscan Model SRE2000/ SRE2100 with Acoustic Rhinometry Module cleared by the FDA?
Rhinoscan Model SRE2000/ SRE2100 with Acoustic Rhinometry Module (K000406) received a 510(k) decision of Substantially Equivalent on April 17, 2000, 70 days after the submission was received.
What is the product code of K000406?
The FDA product code is BXQ – Rhinoanemometer (Measurement Of Nasal Decongestion), a Class II (moderate risk) device regulated under 21 CFR 868.1800.