The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Pressure Transducer Dome 1295c.
Device ID | K841613 |
510k Number | K841613 |
Device Name: | PRESSURE TRANSDUCER DOME 1295C |
Classification | Transducer, Blood-pressure, Extravascular |
Applicant | HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1085 |
Contact | James F Kistler |
Correspondent | James F Kistler HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1085 |
Product Code | DRS |
CFR Regulation Number | 870.2850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-23 |
Decision Date | 1984-10-24 |