The following data is part of a premarket notification filed by Portable Power Systems, Inc. with the FDA for Battery Pack #1014nc.
Device ID | K925674 |
510k Number | K925674 |
Device Name: | BATTERY PACK #1014NC |
Classification | Thermometer, Electronic, Clinical |
Applicant | PORTABLE POWER SYSTEMS, INC. 10336 SOUTH DRANSFELDT RD. Parker, CO 80134 |
Contact | Norman A Premo |
Correspondent | Norman A Premo PORTABLE POWER SYSTEMS, INC. 10336 SOUTH DRANSFELDT RD. Parker, CO 80134 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-10 |
Decision Date | 1993-05-26 |