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 |