Lichen, Bacterial in Line Breathing Filter
FDA 510(k) K980662 · Dhd Healthcare Corp.
510(k) numberK980662
Submission
- Device name
- Lichen, Bacterial in Line Breathing Filter
- Applicant
- Dhd Healthcare Corp.
Wampsville, NY, US - Received
- February 20, 1998
- Decision date
- September 14, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAH – Filter, Bacterial, Breathing-Circuit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5260
- Specialty
- Anesthesiology
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Questions and answers
When was Lichen, Bacterial in Line Breathing Filter cleared by the FDA?
Lichen, Bacterial in Line Breathing Filter (K980662) received a 510(k) decision of Substantially Equivalent on September 14, 1998, 206 days after the submission was received.
What is the product code of K980662?
The FDA product code is CAH – Filter, Bacterial, Breathing-Circuit, a Class II (moderate risk) device regulated under 21 CFR 868.5260.