The following data is part of a premarket notification filed by Sps, Inc. with the FDA for Magnum.
Device ID | K932902 |
510k Number | K932902 |
Device Name: | MAGNUM |
Classification | Monitor, Breathing Frequency |
Applicant | SPS, INC. 6201 NORTH BELTLINE RD. SUITE 115 Irving, TX 75063 |
Contact | Spiekerman |
Correspondent | Spiekerman SPS, INC. 6201 NORTH BELTLINE RD. SUITE 115 Irving, TX 75063 |
Product Code | BZQ |
CFR Regulation Number | 868.2375 [🔎] |
Decision | Se Subject To Tracking Reg (ST) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-15 |
Decision Date | 1994-05-10 |