The following data is part of a premarket notification filed by Datex Division Instrumentarium Corp. with the FDA for Modified Cardiocap Monitor.
| Device ID | K862455 |
| 510k Number | K862455 |
| Device Name: | MODIFIED CARDIOCAP MONITOR |
| Classification | Computer, Blood-pressure |
| Applicant | DATEX DIVISION INSTRUMENTARIUM CORP. C/O PURITAN BENNETT CORP. 265 BALLARDVALE STREET Wilmington, MA 01887 |
| Contact | Kaija Boos |
| Correspondent | Kaija Boos DATEX DIVISION INSTRUMENTARIUM CORP. C/O PURITAN BENNETT CORP. 265 BALLARDVALE STREET Wilmington, MA 01887 |
| Product Code | DSK |
| CFR Regulation Number | 870.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-27 |
| Decision Date | 1986-09-24 |