The following data is part of a premarket notification filed by Foremount Ent. Co., Ltd. with the FDA for Pocket Size Resuscitator/model: M16201r And M16201a.
| Device ID | K042727 |
| 510k Number | K042727 |
| Device Name: | POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A |
| Classification | Valve, Non-rebreathing |
| Applicant | FOREMOUNT ENT. CO., LTD. 9F-4, NO.1 LANE 641 SHEN-LIN SOUTH RD. Ta Ya Hsiang, Taichung, TW 428 |
| Contact | Tyson Hsu |
| Correspondent | Tyson Hsu FOREMOUNT ENT. CO., LTD. 9F-4, NO.1 LANE 641 SHEN-LIN SOUTH RD. Ta Ya Hsiang, Taichung, TW 428 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-01 |
| Decision Date | 2005-03-18 |
| Summary: | summary |