Blower/Mister
FDA 510(k) K983135 · Cardiothoracic Systems, Inc.
510(k) numberK983135
Submission
- Device name
- Blower/Mister
- Applicant
- Cardiothoracic Systems, Inc.
Cupertino, CA, US - Received
- September 8, 1998
- Decision date
- November 13, 1998
- 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 Blower/Mister cleared by the FDA?
Blower/Mister (K983135) received a 510(k) decision of Substantially Equivalent on November 13, 1998, 66 days after the submission was received.
What is the product code of K983135?
The FDA product code is FQH – Lavage, Jet, a Class II (moderate risk) device regulated under 21 CFR 880.5475.