The following data is part of a premarket notification filed by Cheen Houng Ent. Co. Ltd. with the FDA for Pmx Compact Resucitator.
| Device ID | K021390 |
| 510k Number | K021390 |
| Device Name: | PMX COMPACT RESUCITATOR |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | CHEEN HOUNG ENT. CO. LTD. 23 SAN DREEN ST., ALLEY 11, LANE 65 Taipei (shulin), TW 23805 |
| Contact | Jay Wang |
| Correspondent | Jay Wang CHEEN HOUNG ENT. CO. LTD. 23 SAN DREEN ST., ALLEY 11, LANE 65 Taipei (shulin), TW 23805 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-02 |
| Decision Date | 2002-10-04 |