The following data is part of a premarket notification filed by John Mfg., Ltd. with the FDA for Electro-optical Air Sterilizer With Ionizer.
| Device ID | K033448 |
| 510k Number | K033448 |
| Device Name: | ELECTRO-OPTICAL AIR STERILIZER WITH IONIZER |
| Classification | Purifier, Air, Ultraviolet, Medical |
| Applicant | JOHN MFG., LTD. 18780 AMAR ROAD, STE 203-203 Walnut, CA 91789 |
| Contact | Arthur King Ma |
| Correspondent | Arthur King Ma JOHN MFG., LTD. 18780 AMAR ROAD, STE 203-203 Walnut, CA 91789 |
| Product Code | FRA |
| CFR Regulation Number | 880.6500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-29 |
| Decision Date | 2004-07-12 |
| Summary: | summary |