Sunmed's Greenline Fiber Optic Laryngoscope
FDA 510(k) K954438 · Rms Div.
510(k) numberK954438
Submission
- Device name
- Sunmed's Greenline Fiber Optic Laryngoscope
- Applicant
- Rms Div.
Palm Harbor, FL, US - Received
- September 25, 1995
- Decision date
- December 29, 1995
- 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 Sunmed's Greenline Fiber Optic Laryngoscope cleared by the FDA?
Sunmed's Greenline Fiber Optic Laryngoscope (K954438) received a 510(k) decision of Substantially Equivalent on December 29, 1995, 95 days after the submission was received.
What is the product code of K954438?
The FDA product code is CCW – Laryngoscope, Rigid, a Class I (low risk) device regulated under 21 CFR 868.5540.