The following data is part of a premarket notification filed by Respiratory Care, Inc. with the FDA for Circapak.
Device ID | K792268 |
510k Number | K792268 |
Device Name: | CIRCAPAK |
Classification | Set, Tubing And Support, Ventilator (w Harness) |
Applicant | RESPIRATORY CARE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BZO |
CFR Regulation Number | 868.5975 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-11-09 |
Decision Date | 1979-11-27 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CIRCAPAK 73250384 1155462 Dead/Cancelled |
Respiratory Care, Inc. 1980-02-15 |