The following data is part of a premarket notification filed by Honeywell, Inc. with the FDA for Cen Sta Mon Ac/dc Alarm Central Acces Alarm Recor.
Device ID | K863100 |
510k Number | K863100 |
Device Name: | CEN STA MON AC/DC ALARM CENTRAL ACCES ALARM RECOR |
Classification | Electrocardiograph |
Applicant | HONEYWELL, INC. ONE CAMPUS DR. Pleasantville, NY 10570 |
Contact | Steve Brody |
Correspondent | Steve Brody HONEYWELL, INC. ONE CAMPUS DR. Pleasantville, NY 10570 |
Product Code | DPS |
CFR Regulation Number | 870.2340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-08-13 |
Decision Date | 1987-02-03 |