The following data is part of a premarket notification filed by Siemens Corp. with the FDA for Siemens-elema A.b. Servo Humidifier 150.
Device ID | K790681 |
510k Number | K790681 |
Device Name: | SIEMENS-ELEMA A.B. SERVO HUMIDIFIER 150 |
Classification | Condenser, Heat And Moisture (artificial Nose) |
Applicant | SIEMENS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BYD |
CFR Regulation Number | 868.5375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-04-10 |
Decision Date | 1979-04-13 |