The following data is part of a premarket notification filed by Caremed Supply, Inc. with the FDA for Vasopouse Deep Vein Thrombosis Compression Device Model Ipcs, Model Sqs.
Device ID | K122873 |
510k Number | K122873 |
Device Name: | VASOPOUSE DEEP VEIN THROMBOSIS COMPRESSION DEVICE MODEL IPCS, MODEL SQS |
Classification | Sleeve, Limb, Compressible |
Applicant | CAREMED SUPPLY, INC. 7F, NO.2, LANE 235, BAO CHIAO RD NEW TAIPEI CITY Taipei Xen District, CN 23145 |
Contact | Michael Lee |
Correspondent | Michael Lee CAREMED SUPPLY, INC. 7F, NO.2, LANE 235, BAO CHIAO RD NEW TAIPEI CITY Taipei Xen District, CN 23145 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-09-19 |
Decision Date | 2013-01-15 |
Summary: | summary |