The following data is part of a premarket notification filed by Plaxtron Industrial (m) Sdn. Bhd. with the FDA for Plaxtron Suction Unit, Model 88aa51/88aa61 Series.
| Device ID | K120065 |
| 510k Number | K120065 |
| Device Name: | PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES |
| Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
| Applicant | PLAXTRON INDUSTRIAL (M) SDN. BHD. NO. 15-2, LANE 26, MINCYUAN 1ST RD, LINGYA DISTRICT Kaohsiung City, TW 802 |
| Contact | Ming-yie Jan |
| Correspondent | Ming-yie Jan PLAXTRON INDUSTRIAL (M) SDN. BHD. NO. 15-2, LANE 26, MINCYUAN 1ST RD, LINGYA DISTRICT Kaohsiung City, TW 802 |
| Product Code | JCX |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-09 |
| Decision Date | 2012-04-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07045432067132 | K120065 | 000 |
| 07045432067040 | K120065 | 000 |
| 07045432048087 | K120065 | 000 |
| 07045432048056 | K120065 | 000 |
| 07045432046632 | K120065 | 000 |
| 07045432046625 | K120065 | 000 |
| 07045432046601 | K120065 | 000 |
| 07045432046595 | K120065 | 000 |