The following data is part of a premarket notification filed by Instrumentation Industries, Inc. with the FDA for Endotracheal Tube Changers.
| Device ID | K102127 |
| 510k Number | K102127 |
| Device Name: | ENDOTRACHEAL TUBE CHANGERS |
| Classification | Changer, Tube, Endotracheal |
| Applicant | INSTRUMENTATION INDUSTRIES, INC. 2990 INDUSTRIAL BLVD. Bethel Park, PA 15102 |
| Contact | Doris Walter |
| Correspondent | Doris Walter INSTRUMENTATION INDUSTRIES, INC. 2990 INDUSTRIAL BLVD. Bethel Park, PA 15102 |
| Product Code | LNZ |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-29 |
| Decision Date | 2010-08-27 |
| Summary: | summary |