The following data is part of a premarket notification filed by Prima, Inc. with the FDA for Prima Breathing Bags.
| Device ID | K952011 |
| 510k Number | K952011 |
| Device Name: | PRIMA BREATHING BAGS |
| Classification | Set, Tubing And Support, Ventilator (w Harness) |
| Applicant | PRIMA, INC. 1300 25TH ST. PLAZA SUITE 11 Cleveland, TN 37311 |
| Contact | Robert Steinbarger |
| Correspondent | Robert Steinbarger PRIMA, INC. 1300 25TH ST. PLAZA SUITE 11 Cleveland, TN 37311 |
| Product Code | BZO |
| CFR Regulation Number | 868.5975 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-28 |
| Decision Date | 1995-05-22 |