Direct View 2001 Fiberlight
FDA 510(k) K945901 · Mercury Medical
510(k) numberK945901
Submission
- Device name
- Direct View 2001 Fiberlight
- Applicant
- Mercury Medical
Clearwater, FL, US - Received
- December 2, 1994
- Decision date
- December 27, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CCW – Laryngoscope, Rigid
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5540
- Specialty
- Anesthesiology
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Questions and answers
When was Direct View 2001 Fiberlight cleared by the FDA?
Direct View 2001 Fiberlight (K945901) received a 510(k) decision of Substantially Equivalent on December 27, 1994, 25 days after the submission was received.
What is the product code of K945901?
The FDA product code is CCW – Laryngoscope, Rigid, a Class I (low risk) device regulated under 21 CFR 868.5540.