The following data is part of a premarket notification filed by Honeywell, Inc. with the FDA for Patient Selector Function Block.
Device ID | K832212 |
510k Number | K832212 |
Device Name: | PATIENT SELECTOR FUNCTION BLOCK |
Classification | Electrocardiograph |
Applicant | HONEYWELL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DPS |
CFR Regulation Number | 870.2340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-07-06 |
Decision Date | 1983-10-14 |