The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Ecg-1250a Series Cardiofax S And Ecg-1350a Series Cardiofax M.
| Device ID | K072217 |
| 510k Number | K072217 |
| Device Name: | ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M |
| Classification | Electrocardiograph |
| Applicant | NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
| Contact | Jack Coggan |
| Correspondent | Jack Coggan NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-09 |
| Decision Date | 2007-08-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841983103954 | K072217 | 000 |
| 00841983101069 | K072217 | 000 |
| 00841983101380 | K072217 | 000 |
| 00841983102110 | K072217 | 000 |
| 00841983102387 | K072217 | 000 |
| 00841983102394 | K072217 | 000 |
| 04931921110690 | K072217 | 000 |
| 04931921110713 | K072217 | 000 |
| 04931921113363 | K072217 | 000 |
| 04931921121153 | K072217 | 000 |
| 04931921841457 | K072217 | 000 |
| 04931921864579 | K072217 | 000 |
| 04931921873830 | K072217 | 000 |
| 10841983103947 | K072217 | 000 |
| 00841983100871 | K072217 | 000 |