POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A
FDA 510(k) clearance K042727 · decided 2005-03-18
Clearance details
- K-number
- K042727
- Device name
- POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A
- Applicant
- Foremount Ent. Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2004-10-01
- Decision date
- 2005-03-18
- Days to decision
- 168 days
- Clearance type
- Traditional
- Product code
- CBP
- Device class
- 2
- Regulation number
- 868.5870
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Ta Ya Hsiang, Taichung, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.