CLM Laryngoscope
FDA 510(k) K953179 · Penlon , Ltd.
510(k) numberK953179
Submission
- Device name
- CLM Laryngoscope
- Applicant
- Penlon , Ltd.
Oxonn, GB - Received
- July 10, 1995
- Decision date
- October 6, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| K984101 | FlexibladeCCW · Traditional | Arco Medic , Ltd. | 09/03/1999SE |
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Questions and answers
When was CLM Laryngoscope cleared by the FDA?
CLM Laryngoscope (K953179) received a 510(k) decision of Substantially Equivalent on October 6, 1995, 88 days after the submission was received.
What is the product code of K953179?
The FDA product code is CCW – Laryngoscope, Rigid, a Class I (low risk) device regulated under 21 CFR 868.5540.