The following data is part of a premarket notification filed by Chrono-log Corp. with the FDA for Aggro/link Vw Cofactor Software.
Device ID | K940792 |
510k Number | K940792 |
Device Name: | AGGRO/LINK VW COFACTOR SOFTWARE |
Classification | System, Automated Platelet Aggregation |
Applicant | CHRONO-LOG CORP. 2 WEST PARK RD. Havertown, PA 19083 |
Contact | Nicholas J Veriabo |
Correspondent | Nicholas J Veriabo CHRONO-LOG CORP. 2 WEST PARK RD. Havertown, PA 19083 |
Product Code | JOZ |
CFR Regulation Number | 864.5700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-22 |
Decision Date | 1994-10-13 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00811476011670 | K940792 | 000 |
00811476011045 | K940792 | 000 |