The following data is part of a premarket notification filed by Portable Power Systems, Inc. with the FDA for Battery Pack #1005nc.
Device ID | K931348 |
510k Number | K931348 |
Device Name: | BATTERY PACK #1005NC |
Classification | Pump, Portable, Aspiration (manual Or Powered) |
Applicant | PORTABLE POWER SYSTEMS, INC. 1940 TEE LN. Castle Rock, CO 80104 |
Contact | Norman Premo |
Correspondent | Norman Premo PORTABLE POWER SYSTEMS, INC. 1940 TEE LN. Castle Rock, CO 80104 |
Product Code | BTA |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-17 |
Decision Date | 1994-02-17 |