The following data is part of a premarket notification filed by Dongguan E-test Technology Co., Ltd with the FDA for Automatic Upper Arm Blood Pressure Monitor.
| Device ID | K193627 |
| 510k Number | K193627 |
| Device Name: | Automatic Upper Arm Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Dongguan E-Test Technology Co., LTD Room 201,301. Building 1, Changping Section No.1 Dongshen Road Dongguan, CN 523588 |
| Contact | Victor Wan |
| Correspondent | Cassie Lee DONGGUAN E-TEST TECHNOLOGY CO., LTD Room 201,301. Building 1, Changping Section No.1, Dongshen R Dongguan City, CN 523588 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-26 |
| Decision Date | 2020-07-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973826010680 | K193627 | 000 |
| 06973826010567 | K193627 | 000 |
| 06973826010574 | K193627 | 000 |
| 06973826010581 | K193627 | 000 |
| 06973826010598 | K193627 | 000 |
| 06973826010604 | K193627 | 000 |
| 06973826010611 | K193627 | 000 |
| 06973826010628 | K193627 | 000 |
| 06973826010635 | K193627 | 000 |
| 06973826010642 | K193627 | 000 |
| 06973826010659 | K193627 | 000 |
| 06973826010666 | K193627 | 000 |
| 06973826010673 | K193627 | 000 |
| 06973826010550 | K193627 | 000 |