The following data is part of a premarket notification filed by Aptek Ltd. with the FDA for Aptek Ultrasound Procedure Tray.
| Device ID | K802666 |
| 510k Number | K802666 |
| Device Name: | APTEK ULTRASOUND PROCEDURE TRAY |
| Classification | Sampler, Amniotic Fluid (amniocentesis Tray) |
| Applicant | APTEK LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HIO |
| CFR Regulation Number | 884.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-28 |
| Decision Date | 1980-11-26 |