Submission Details
| 510(k) Number | K102127 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 29, 2010 |
| Decision Date | August 27, 2010 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Special
K102127 - ENDOTRACHEAL TUBE CHANGERS
(FDA 510(k) Clearance)
Aug 2010
Decision
29d
Days
Class 2
Risk
K102127 is an FDA 510(k) clearance for the ENDOTRACHEAL TUBE CHANGERS, a Changer, Tube, Endotracheal (Class II — Special Controls, product code LNZ), submitted by Instrumentation Industries, Inc. (Bethel Park, US). The FDA issued a Cleared decision on August 27, 2010, 29 days after receiving the submission on July 29, 2010. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5730.
Device Classification
| Product Code | LNZ — Changer, Tube, Endotracheal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5730 |