The following data is part of a premarket notification filed by Sandhill Scientific, Inc. with the FDA for Eisman-tries Mep (multiple Electrode Probe).
Device ID | K926218 |
510k Number | K926218 |
Device Name: | EISMAN-TRIES MEP (MULTIPLE ELECTRODE PROBE) |
Classification | Perineometer |
Applicant | SANDHILL SCIENTIFIC, INC. 1501-N WEST CAMPUS DR. Littleton, CO 80120 -4535 |
Contact | Jacqueline Q Thomas |
Correspondent | Jacqueline Q Thomas SANDHILL SCIENTIFIC, INC. 1501-N WEST CAMPUS DR. Littleton, CO 80120 -4535 |
Product Code | HIR |
CFR Regulation Number | 884.1425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-10 |
Decision Date | 1994-08-26 |