The following data is part of a premarket notification filed by Cardiac Pacemakers, Inc. with the FDA for Pdt Carryall Transmitter, Various Models.
| Device ID | K912379 |
| 510k Number | K912379 |
| Device Name: | PDT CARRYALL TRANSMITTER, VARIOUS MODELS |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | CARDIAC PACEMAKERS, INC. 4100 HAMLINE AVE., NORTH P.O. BOX 64079 St. Paul, MN 55112 -5798 |
| Contact | Cathy Yohnk |
| Correspondent | Cathy Yohnk CARDIAC PACEMAKERS, INC. 4100 HAMLINE AVE., NORTH P.O. BOX 64079 St. Paul, MN 55112 -5798 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-29 |
| Decision Date | 1991-06-17 |