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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719871891896 | K042727 | 000 |
| 04719871890677 | K042727 | 000 |
| 04719871890653 | K042727 | 000 |
| 04719871890646 | K042727 | 000 |
| 04719871890639 | K042727 | 000 |
| 04719871890622 | K042727 | 000 |
| 04719871890615 | K042727 | 000 |
| 04719871890608 | K042727 | 000 |
| 04719871890110 | K042727 | 000 |
| 04719871890103 | K042727 | 000 |
| 04719871890097 | K042727 | 000 |
| 04719871890080 | K042727 | 000 |
| 04719871890073 | K042727 | 000 |
| 04719871890066 | K042727 | 000 |
| 04719871890059 | K042727 | 000 |
| 04719871890042 | K042727 | 000 |
| 04719871890028 | K042727 | 000 |
| 04719871890691 | K042727 | 000 |
| 04719871890707 | K042727 | 000 |
| 04719871891889 | K042727 | 000 |
| 04719871891605 | K042727 | 000 |
| 04719871891599 | K042727 | 000 |
| 04719871891582 | K042727 | 000 |
| 04719871891001 | K042727 | 000 |
| 04719871890936 | K042727 | 000 |
| 04719871890929 | K042727 | 000 |
| 04719871890912 | K042727 | 000 |
| 04719871890905 | K042727 | 000 |
| 04719871890899 | K042727 | 000 |
| 04719871890882 | K042727 | 000 |
| 04719871890875 | K042727 | 000 |
| 04719871890745 | K042727 | 000 |
| 04719871890738 | K042727 | 000 |
| 04719871890721 | K042727 | 000 |
| 04719871890714 | K042727 | 000 |
| 04719871890011 | K042727 | 000 |