The following data is part of a premarket notification filed by Instrumentarium Corp. with the FDA for Cardiocap Monitor.
| Device ID | K853953 |
| 510k Number | K853953 |
| Device Name: | CARDIOCAP MONITOR |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | INSTRUMENTARIUM CORP. C/O PURITAN-BENNETT 265 BALLARDVALE STREET Wilmington, MA 01887 |
| Contact | Olli Riikkala |
| Correspondent | Olli Riikkala INSTRUMENTARIUM CORP. C/O PURITAN-BENNETT 265 BALLARDVALE STREET Wilmington, MA 01887 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-25 |
| Decision Date | 1986-06-02 |