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 |