The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Filter/hch Product Number 5710hepa, 5710filt.
| Device ID | K950447 |
| 510k Number | K950447 |
| Device Name: | FILTER/HCH PRODUCT NUMBER 5710HEPA, 5710FILT |
| Classification | Condenser, Heat And Moisture (artificial Nose) |
| Applicant | VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Contact | Jing Zhang |
| Correspondent | Jing Zhang 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 | 1995-02-03 |
| Decision Date | 1995-02-21 |