The following data is part of a premarket notification filed by Venner Medical (singapore) Pte Ltd with the FDA for Venner Tracheal Seal Monitor.
| Device ID | K110631 |
| 510k Number | K110631 |
| Device Name: | VENNER TRACHEAL SEAL MONITOR |
| Classification | Cuff, Tracheal Tube, Inflatable |
| Applicant | VENNER MEDICAL (SINGAPORE) PTE LTD 7 Trail House Court Rockville, MD 20850 |
| Contact | Hchristine Brauer, Ph.d. |
| Correspondent | Hchristine Brauer, Ph.d. VENNER MEDICAL (SINGAPORE) PTE LTD 7 Trail House Court Rockville, MD 20850 |
| Product Code | BSK |
| CFR Regulation Number | 868.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-04 |
| Decision Date | 2011-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08885009190707 | K110631 | 000 |