The following data is part of a premarket notification filed by Natural Energy Solutions Ag with the FDA for Airnergy+stream.
Device ID | K052492 |
510k Number | K052492 |
Device Name: | AIRNERGY+STREAM |
Classification | Lamp, Infrared, Therapeutic Heating |
Applicant | NATURAL ENERGY SOLUTIONS AG EISENHUTWEG 15 Kumhausen-preisenberg, DE 84036 |
Contact | Martina Gunderoth |
Correspondent | Martina Gunderoth NATURAL ENERGY SOLUTIONS AG EISENHUTWEG 15 Kumhausen-preisenberg, DE 84036 |
Product Code | ILY |
CFR Regulation Number | 890.5500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-09-12 |
Decision Date | 2006-09-05 |
Summary: | summary |