The following data is part of a premarket notification filed by Mediserve Information Systems, Inc. with the FDA for Ventlink System.
| Device ID | K052751 |
| 510k Number | K052751 |
| Device Name: | VENTLINK SYSTEM |
| Classification | Accessory To Continuous Ventilator (respirator) |
| Applicant | MEDISERVE INFORMATION SYSTEMS, INC. 3225 S. HARDY DR., SUITE 101 Tempe, AZ 85282 |
| Contact | Mark Ofori-kyei |
| Correspondent | Mark Ofori-kyei MEDISERVE INFORMATION SYSTEMS, INC. 3225 S. HARDY DR., SUITE 101 Tempe, AZ 85282 |
| Product Code | MOD |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-30 |
| Decision Date | 2005-12-23 |
| Summary: | summary |