The following data is part of a premarket notification filed by Simex Medizintechnik Gmbh with the FDA for Simex Subglottic Aspiration System.
| Device ID | K141255 |
| 510k Number | K141255 |
| Device Name: | SIMEX SUBGLOTTIC ASPIRATION SYSTEM |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | SIMEX MEDIZINTECHNIK GMBH P.O. BOX 123 Tarrytown, NY 10591 |
| Contact | Hamid Khosrowshahi |
| Correspondent | Hamid Khosrowshahi SIMEX MEDIZINTECHNIK GMBH P.O. BOX 123 Tarrytown, NY 10591 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-14 |
| Decision Date | 2014-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04052262385964 | K141255 | 000 |
| 04052262385957 | K141255 | 000 |