The following data is part of a premarket notification filed by Longfian Scitech Co., Ltd. with the FDA for Longfian Oxygen Concentrator.
| Device ID | K131968 |
| 510k Number | K131968 |
| Device Name: | LONGFIAN OXYGEN CONCENTRATOR |
| Classification | Generator, Oxygen, Portable |
| Applicant | LONGFIAN SCITECH CO., LTD. 6840 SW 45TH LN UNIT 5 Miami, FL 33155 |
| Contact | Jun Peng |
| Correspondent | Jun Peng LONGFIAN SCITECH CO., LTD. 6840 SW 45TH LN UNIT 5 Miami, FL 33155 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-28 |
| Decision Date | 2014-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853041003819 | K131968 | 000 |
| 00853041003796 | K131968 | 000 |
| 00853041003703 | K131968 | 000 |
| 06934726614033 | K131968 | 000 |
| 00616784080017 | K131968 | 000 |
| 00840117310254 | K131968 | 000 |