The following data is part of a premarket notification filed by Airos Medical, Inc. with the FDA for Airos 6 Sequential Compression Device.
Device ID | K193069 |
510k Number | K193069 |
Device Name: | AIROS 6 Sequential Compression Device |
Classification | Sleeve, Limb, Compressible |
Applicant | AIROS Medical, Inc. 2501 Monroe Blvd. Suite 1200 Audubon, PA 19403 |
Contact | Darren Behuniak |
Correspondent | Darren Behuniak AIROS Medical, Inc. 2501 Monroe Blvd. Suite 1200 Audubon, PA 19403 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-11-04 |
Decision Date | 2019-12-04 |