The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Bacterial/viral Filter Product Numbers 5100filt, 5100thinm, 5100hepa.
| Device ID | K951047 |
| 510k Number | K951047 |
| Device Name: | BACTERIAL/VIRAL FILTER PRODUCT NUMBERS 5100FILT, 5100THINM, 5100HEPA |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Contact | Steve Lieberman |
| Correspondent | Steve Lieberman VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-06 |
| Decision Date | 1995-06-02 |