Clearview Blower/Mister
FDA 510(k) K973485 · Dlp, Inc.
510(k) numberK973485
Submission
- Device name
- Clearview Blower/Mister
- Applicant
- Dlp, Inc.
Grand Rapids, MI, US - Received
- September 15, 1997
- Decision date
- December 8, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FQH – Lavage, Jet
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5475
- Specialty
- General Hospital
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Questions and answers
When was Clearview Blower/Mister cleared by the FDA?
Clearview Blower/Mister (K973485) received a 510(k) decision of Substantially Equivalent on December 8, 1997, 84 days after the submission was received.
What is the product code of K973485?
The FDA product code is FQH – Lavage, Jet, a Class II (moderate risk) device regulated under 21 CFR 880.5475.