The following data is part of a premarket notification filed by Ageless Health Industrial with the FDA for Age Automatic Upper Arm Blood Pressure Monitor.
| Device ID | K123882 |
| 510k Number | K123882 |
| Device Name: | AGE AUTOMATIC UPPER ARM BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | AGELESS HEALTH INDUSTRIAL 3F, A1 BLDG, DONGSHEN SIMA INDUSTRIAL AREA NO. 33 SHENBEI ROAD, CHANGPING Dongguan, Guangdong, CN 523570 |
| Contact | Victor Wan |
| Correspondent | Victor Wan AGELESS HEALTH INDUSTRIAL 3F, A1 BLDG, DONGSHEN SIMA INDUSTRIAL AREA NO. 33 SHENBEI ROAD, CHANGPING Dongguan, Guangdong, CN 523570 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-17 |
| Decision Date | 2013-08-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06958682800279 | K123882 | 000 |
| 00888277361228 | K123882 | 000 |
| 00884389106955 | K123882 | 000 |
| 06958682800088 | K123882 | 000 |
| 06958682800101 | K123882 | 000 |
| 06958682800163 | K123882 | 000 |
| 06958682800187 | K123882 | 000 |
| 06958682800224 | K123882 | 000 |
| 06958682800255 | K123882 | 000 |
| 00888277362089 | K123882 | 000 |