The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Stresswriter Exercise Testing System.
Device ID | K961009 |
510k Number | K961009 |
Device Name: | STRESSWRITER EXERCISE TESTING SYSTEM |
Classification | Computer, Diagnostic, Programmable |
Applicant | HEWLETT-PACKARD CO. 1700 SOUTH BAKER ST. Mcminnville, OR 97128 |
Contact | Nancy Winn |
Correspondent | Nancy Winn HEWLETT-PACKARD CO. 1700 SOUTH BAKER ST. Mcminnville, OR 97128 |
Product Code | DQK |
CFR Regulation Number | 870.1425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-03-12 |
Decision Date | 1996-06-17 |
Summary: | summary |