The following data is part of a premarket notification filed by Rabar, Inc. with the FDA for Echo-pulse Km555.
| Device ID | K821736 |
| 510k Number | K821736 |
| Device Name: | ECHO-PULSE KM555 |
| Classification | Echoencephalograph |
| Applicant | RABAR, INC. 111 ONETA RD. Rochester, NY 14617 |
| Contact | Bernard Weinstein |
| Correspondent | Bernard Weinstein RABAR, INC. 111 ONETA RD. Rochester, NY 14617 |
| Product Code | GXW |
| CFR Regulation Number | 882.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-14 |
| Decision Date | 1982-12-09 |