The following data is part of a premarket notification filed by Siemens Elema Ab with the FDA for Compressor Mini, 115 V, Model 64 81 779 Eh81e.
| Device ID | K023354 |
| 510k Number | K023354 |
| Device Name: | COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E |
| Classification | Compressor, Air, Portable |
| Applicant | SIEMENS ELEMA AB 16 ELECTRONICS AVE. Danvers, MA 01923 |
| Contact | Steve Sheehan |
| Correspondent | Steve Sheehan SIEMENS ELEMA AB 16 ELECTRONICS AVE. Danvers, MA 01923 |
| Product Code | BTI |
| CFR Regulation Number | 868.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-07 |
| Decision Date | 2003-09-05 |
| Summary: | summary |