The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Esophogral Multiprobe.
Device ID | K832903 |
510k Number | K832903 |
Device Name: | ESOPHOGRAL MULTIPROBE |
Classification | Electrode, Electrocardiograph |
Applicant | VITAL SIGNS, INC. 1 MADISON ST. East Rutherford, NJ 07073 |
Contact | John C Riley |
Correspondent | John C Riley VITAL SIGNS, INC. 1 MADISON ST. East Rutherford, NJ 07073 |
Product Code | DRX |
CFR Regulation Number | 870.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-08-29 |
Decision Date | 1984-05-23 |