Sunlite Laryngoscope
FDA 510(k) K921263 · Sunmed, Inc.
510(k) numberK921263
Submission
- Device name
- Sunlite Laryngoscope
- Applicant
- Sunmed, Inc.
Clearwater, FL, US - Received
- March 16, 1992
- Decision date
- June 1, 1993
- 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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| K984101 | FlexibladeCCW · Traditional | Arco Medic , Ltd. | 09/03/1999SE |
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| K955632 | Orthoplug Soft Bone DesignLZN · Traditional | 02/27/1996SE |
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Questions and answers
When was Sunlite Laryngoscope cleared by the FDA?
Sunlite Laryngoscope (K921263) received a 510(k) decision of Substantially Equivalent on June 1, 1993, 442 days after the submission was received.
What is the product code of K921263?
The FDA product code is CCW – Laryngoscope, Rigid, a Class I (low risk) device regulated under 21 CFR 868.5540.