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 |