Endotracheal Tube Changers
FDA 510(k) K102127 · Instrumentation Industries, Inc.
510(k) numberK102127
Submission
- Device name
- Endotracheal Tube Changers
- Applicant
- Instrumentation Industries, Inc.
Bethel Park, PA, US - Received
- July 29, 2010
- Decision date
- August 27, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LNZ – Changer, Tube, Endotracheal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5730
- Specialty
- Anesthesiology
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Questions and answers
When was Endotracheal Tube Changers cleared by the FDA?
Endotracheal Tube Changers (K102127) received a 510(k) decision of Substantially Equivalent on August 27, 2010, 29 days after the submission was received.
What is the product code of K102127?
The FDA product code is LNZ – Changer, Tube, Endotracheal, a Class II (moderate risk) device regulated under 21 CFR 868.5730.