The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Codemaster Xl + Xl W/shock Advisory Option.
Device ID | K954957 |
510k Number | K954957 |
Device Name: | CODEMASTER XL + XL W/SHOCK ADVISORY OPTION |
Classification | Automated External Defibrillators (non-wearable) |
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 | MKJ |
CFR Regulation Number | 870.5310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-10-27 |
Decision Date | 1996-05-07 |
Summary: | summary |