The following data is part of a premarket notification filed by Reynolds Medical Ltd. with the FDA for Lifecard Cf 7 Day.
Device ID | K011837 |
510k Number | K011837 |
Device Name: | LIFECARD CF 7 DAY |
Classification | Electrocardiograph, Ambulatory (without Analysis) |
Applicant | REYNOLDS MEDICAL LTD. 377 RT. 17 S. Hasbrouck Heights, NJ 07604 |
Contact | George Myers |
Correspondent | George Myers REYNOLDS MEDICAL LTD. 377 RT. 17 S. Hasbrouck Heights, NJ 07604 |
Product Code | MWJ |
CFR Regulation Number | 870.2800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-06-12 |
Decision Date | 2001-07-13 |
Summary: | summary |