The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Saecg Cardiograph Model M1754a.
| Device ID | K913997 |
| 510k Number | K913997 |
| Device Name: | SAECG CARDIOGRAPH MODEL M1754A |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | HEWLETT-PACKARD CO. 1700 SOUTH BAKER ST. Mcminnville, OR 97128 |
| Contact | Monica Ferrante |
| Correspondent | Monica Ferrante HEWLETT-PACKARD CO. 1700 SOUTH BAKER ST. Mcminnville, OR 97128 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-06 |
| Decision Date | 1992-03-06 |