The following data is part of a premarket notification filed by Spectramed, Inc. with the FDA for Model Dt-bal, Balance Saver.
Device ID | K895323 |
510k Number | K895323 |
Device Name: | MODEL DT-BAL, BALANCE SAVER |
Classification | Monitor, Pressure, Intrauterine |
Applicant | SPECTRAMED, INC. 1900 WILLIAMS DR. Oxnard, CA 93030 |
Contact | Robert Leavitt |
Correspondent | Robert Leavitt SPECTRAMED, INC. 1900 WILLIAMS DR. Oxnard, CA 93030 |
Product Code | KXO |
CFR Regulation Number | 884.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-08-29 |
Decision Date | 1989-10-24 |