510(k) K170663
- Device
- Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer
- Applicant
- Foremount Enterprise Co., Ltd.
- 510(k) number
- K170663
- Product code
- BTM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-05-11
- Date received
- 2017-03-06
- Regulation
- 868.5915
- Classification name
- Ventilator, Emergency, Manual (resuscitator)
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- John Yang
- Address
- # 17, Aly. 15, Ln. 5, Shenan St., Shengang Dist., Taichung City TW 42944 42944
FDA Registration Numbers#
- 3013557562
- 3034669683
- 3006061749
- 1832562
- 3014507910
- 8021995
- 3011137372
- 3022631687
- 9612374
- 9617604
- 8043316
- 9710567
- 3005609751
- 3030308442
- 3036470679
- 9681848
- 3011987967
- 3010272829
- 1417592
- 3005587132
- 2030745
- 3012307300
- 2022648
- 2518436
- 3027977504
- 3008311916
- 9610849
- 3016761372
- 3008806809
- 3007734888
- 3017708978
- 3013484413
- 3011503227
- 2020813
- 3003902679
- 3008729547
- 8044169
- 9616445
- 3006783791
- 9610691
- 1526863
- 3031369651
- 9610861
- 3003898360
- 3014656749
- 8030673
- 3038430561
- 3003924186
- 1314417
- 3004111573
- 2028807
- 9610483
- 3008261717
- 3012104670
- 3024753104
- 3038772438
- 3020460367
- 3004993040
- 2518157
- 9616354
- 9710391
- 3008818980
- 2024500
- 3005621729
- 1924066
- 3010042047
- 3006157842
- 3015997711
- 3003862188
- 2648727
- 3015191173
- 3008264081
- 3004365956
- 3010402691
- 1024404
- 3014220748
Source Documents#
Other 510(k) Records For Product Code BTM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251631 | The BAG manual resuscitator and accessories | Laerdal Medical AS | 2025-11-24 |
| K243861 | butterflyBVM | Compact Medical, Inc. | 2025-04-25 |
| K221841 | EOlife® | Archeon | 2023-03-18 |
| K212905 | Sotair Device | Safe Bvm Corporation | 2022-08-18 |
| K210288 | Disposable Manual Resuscitator | Xiamen Compower Medical Tech. Co., Ltd. | 2021-08-26 |
| K181583 | Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20 | Flexicare Medical Limited. | 2018-12-07 |
| K152931 | Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator | Ambu A/S | 2016-08-29 |
| K132172 | NEONATALIE RESUSCITATOR | Laerdal Medical A/S | 2015-01-15 |
| K112852 | BABI PLUS NEONATAL RESUSCITATION BAG | A Plus Medical | 2012-01-13 |
| K102824 | AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC | Ambu A/S | 2011-01-28 |
| K102649 | NEOPOP INFANT RESUSCITATOR WITH FLOW METER | Neoforce Group, Inc. | 2011-01-06 |
| K094003 | REVIVATOR | Hersill, S.L. | 2010-09-17 |
| K093081 | POCKET BVM | Microbvm Systems , Ltd. | 2010-02-05 |
| K082092 | DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE | Galemed Corp. | 2008-10-15 |
| K073410 | SAVE RESUSCITATOR | Artivent Corporation | 2008-09-12 |
Legacy Summary#
summary
FDA Review#
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