The following data is part of a premarket notification filed by Huntleigh Healthcare, Inc. with the FDA for Multi Dopplex Ii / Fetal Dopplex Ii.
| Device ID | K930200 |
| 510k Number | K930200 |
| Device Name: | MULTI DOPPLEX II / FETAL DOPPLEX II |
| Classification | Monitor, Ultrasonic, Fetal |
| Applicant | HUNTLEIGH HEALTHCARE, INC. 40 CHRISTOPHER WAY Eatontown, NJ 07724 -3327 |
| Contact | Andy Wood |
| Correspondent | Andy Wood HUNTLEIGH HEALTHCARE, INC. 40 CHRISTOPHER WAY Eatontown, NJ 07724 -3327 |
| Product Code | KNG |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-14 |
| Decision Date | 1994-06-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051968032058 | K930200 | 000 |
| 05051968019301 | K930200 | 000 |
| 05051968019172 | K930200 | 000 |
| 05051968018496 | K930200 | 000 |
| 05051968017666 | K930200 | 000 |
| 05051968017642 | K930200 | 000 |
| 05051968017277 | K930200 | 000 |
| 05051968016799 | K930200 | 000 |
| 05051968013408 | K930200 | 000 |
| 05051968013125 | K930200 | 000 |
| 05051968013118 | K930200 | 000 |
| 05051968013095 | K930200 | 000 |
| 05051968013088 | K930200 | 000 |
| 05051968021281 | K930200 | 000 |
| 05051968022912 | K930200 | 000 |
| 05051968022950 | K930200 | 000 |
| 05051968031761 | K930200 | 000 |
| 05051968031747 | K930200 | 000 |
| 05051968030542 | K930200 | 000 |
| 05051968030535 | K930200 | 000 |
| 05051968030054 | K930200 | 000 |
| 05051968030047 | K930200 | 000 |
| 05051968029539 | K930200 | 000 |
| 05051968029454 | K930200 | 000 |
| 05051968029416 | K930200 | 000 |
| 05051968029379 | K930200 | 000 |
| 05051968024459 | K930200 | 000 |
| 05051968023070 | K930200 | 000 |
| 05051968009975 | K930200 | 000 |