K150034 is an FDA 510(k) clearance for the AMT Enteral Transition Adapters. This device is classified as a Enteral Specific Transition Connectors (Class II - Special Controls, product code PIO).
Submitted by Applied Medical Technology, Inc. (Brecksville, US). The FDA issued a Cleared decision on June 9, 2015, 151 days after receiving the submission on January 9, 2015.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980. Facilitates Enteral Specific Connections Between Aami/cn3(ps):2014 Compliant Connectors And Non Iso 80369-1 Compliant Legacy Enteral Connectors..
| 510(k) Number | K150034 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 2015 |
| Decision Date | June 09, 2015 |
| Days to Decision | 151 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | PIO — Enteral Specific Transition Connectors |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |
| Definition | Facilitates Enteral Specific Connections Between Aami/cn3(ps):2014 Compliant Connectors And Non Iso 80369-1 Compliant Legacy Enteral Connectors. |