The following data is part of a premarket notification filed by Intellimetrics Instrument Corp. with the FDA for Cath Lab Automated Interactive Recorder Systems.
| Device ID | K900814 |
| 510k Number | K900814 |
| Device Name: | CATH LAB AUTOMATED INTERACTIVE RECORDER SYSTEMS |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | INTELLIMETRICS INSTRUMENT CORP. 8 MIDDLESEX TECHNOLOGY CENTER 900 MIDDLESEX TURNPIKE Billerica, MA 01821 |
| Contact | Eric D Kapust |
| Correspondent | Eric D Kapust INTELLIMETRICS INSTRUMENT CORP. 8 MIDDLESEX TECHNOLOGY CENTER 900 MIDDLESEX TURNPIKE Billerica, MA 01821 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-21 |
| Decision Date | 1990-12-17 |