The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Accucom 2.
| Device ID | K874138 |
| 510k Number | K874138 |
| Device Name: | ACCUCOM 2 |
| Classification | Probe, Blood-flow, Extravascular |
| Applicant | DATASCOPE CORP. 580 WINTERS AVE. P.O. BOX 5 Paramus, NJ 07653 |
| Contact | Arthur Friedman |
| Correspondent | Arthur Friedman DATASCOPE CORP. 580 WINTERS AVE. P.O. BOX 5 Paramus, NJ 07653 |
| Product Code | DPT |
| CFR Regulation Number | 870.2120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-13 |
| Decision Date | 1988-06-01 |