The following data is part of a premarket notification filed by Awareness Technology, Inc. with the FDA for Stat Fax 2600.
Device ID | K941394 |
510k Number | K941394 |
Device Name: | STAT FAX 2600 |
Classification | Station, Pipetting And Diluting, For Clinical Use |
Applicant | AWARENESS TECHNOLOGY, INC. 1995 SW MARTIN HWY. P.O. BOX 1679 Palm City, FL 34990 |
Contact | Mary Freeman |
Correspondent | Mary Freeman AWARENESS TECHNOLOGY, INC. 1995 SW MARTIN HWY. P.O. BOX 1679 Palm City, FL 34990 |
Product Code | JQW |
CFR Regulation Number | 862.2750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-03-22 |
Decision Date | 1994-06-03 |