The following data is part of a premarket notification filed by Mini-mitter Co., Inc. with the FDA for Mini-logger Series 2000.
Device ID | K991045 |
510k Number | K991045 |
Device Name: | MINI-LOGGER SERIES 2000 |
Classification | Conditioner, Signal, Physiological |
Applicant | MINI-MITTER CO., INC. PO BOX 3386 Sunriver, OR 97707 |
Contact | Jack E Mckenzie |
Correspondent | Jack E Mckenzie MINI-MITTER CO., INC. PO BOX 3386 Sunriver, OR 97707 |
Product Code | GWK |
CFR Regulation Number | 882.1845 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-03-29 |
Decision Date | 1999-09-21 |
Summary: | summary |