The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Piggyback Breathing Circuit.
Device ID | K791034 |
510k Number | K791034 |
Device Name: | PIGGYBACK BREATHING CIRCUIT |
Classification | Set, Tubing And Support, Ventilator (w Harness) |
Applicant | VITAL SIGNS, INC. 1 MADISON ST. East Rutherford, NJ 07073 |
Contact | Terence D Wall |
Correspondent | Terence D Wall VITAL SIGNS, INC. 1 MADISON ST. East Rutherford, NJ 07073 |
Product Code | BZO |
CFR Regulation Number | 868.5975 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-06-05 |
Decision Date | 1979-06-15 |