The following data is part of a premarket notification filed by Medtech Industries, Inc. with the FDA for Card Guard, Model Cg-2000a.
| Device ID | K910451 |
| 510k Number | K910451 |
| Device Name: | CARD GUARD, MODEL CG-2000A |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | MEDTECH INDUSTRIES, INC. C/O HOGAN & HARTSON 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan MEDTECH INDUSTRIES, INC. C/O HOGAN & HARTSON 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-01 |
| Decision Date | 1991-06-10 |