The following data is part of a premarket notification filed by Polymed (xiamen) Plastic Industrial Co.,ltd. with the FDA for Simplify Compact Resuscitator.
| Device ID | K021716 |
| 510k Number | K021716 |
| Device Name: | SIMPLIFY COMPACT RESUSCITATOR |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | POLYMED (XIAMEN) PLASTIC INDUSTRIAL CO.,LTD. UNIT B,1-5 F,WAREHOUSE & PROC. COMPLEX BLDG. XIANGYU F.T.Z. Xiamen, CN |
| Contact | Shan Hua Ying |
| Correspondent | Shan Hua Ying POLYMED (XIAMEN) PLASTIC INDUSTRIAL CO.,LTD. UNIT B,1-5 F,WAREHOUSE & PROC. COMPLEX BLDG. XIANGYU F.T.Z. Xiamen, CN |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-23 |
| Decision Date | 2002-10-08 |