The following data is part of a premarket notification filed by Physio-control Corp. with the FDA for Telemetry Receiver Accessory For The Cms 8000.
Device ID | K894540 |
510k Number | K894540 |
Device Name: | TELEMETRY RECEIVER ACCESSORY FOR THE CMS 8000 |
Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
Applicant | PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E. P.O. BOX 97006 Redmond, WA 98073 -9706 |
Contact | Sherri L Pocock |
Correspondent | Sherri L Pocock PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E. P.O. BOX 97006 Redmond, WA 98073 -9706 |
Product Code | DXH |
CFR Regulation Number | 870.2920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-07-20 |
Decision Date | 1989-10-12 |