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 |