Westmed Condesate Collection Trap
FDA 510(k) K954271 · Westmed Intl.
510(k) numberK954271
Submission
- Device name
- Westmed Condesate Collection Trap
- Applicant
- Westmed Intl.
Tucson, AZ, US - Received
- September 12, 1995
- Decision date
- December 28, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAW – Generator, Oxygen, Portable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5440
- Specialty
- Anesthesiology
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Questions and answers
When was Westmed Condesate Collection Trap cleared by the FDA?
Westmed Condesate Collection Trap (K954271) received a 510(k) decision of Substantially Equivalent on December 28, 1995, 107 days after the submission was received.
What is the product code of K954271?
The FDA product code is CAW – Generator, Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5440.