The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for 5701, 5702, 5704, 5706 Hygroscopic Condenser Humid.
Device ID | K923865 |
510k Number | K923865 |
Device Name: | 5701, 5702, 5704, 5706 HYGROSCOPIC CONDENSER HUMID |
Classification | Condenser, Heat And Moisture (artificial Nose) |
Applicant | VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
Contact | Charles J Klein |
Correspondent | Charles J Klein VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
Product Code | BYD |
CFR Regulation Number | 868.5375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-03 |
Decision Date | 1993-02-01 |