FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE
K Number: K133957
·
Decision Apr 14, 2014
Classifications
1
FEI Numbers
71
Registration Numbers
72
Same Product Code
79
Applicant Total
7
Review Days
112
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Basic Information
- Device Name
- DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE
- K Number
- K133957
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5965
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Galemed Corp.
- Date Received
- December 23, 2013
- Decision Date
- April 14, 2014
- Product Code
- BYE
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | FDA class 2 | Anesthesiology |
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Other Clearances by Galemed Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K132679 | AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER | Apr 18, 2014 | Substantially Equivalent |
| K122627 | GIO DIGITAL PRESSURE GUAGES | Aug 22, 2013 | Substantially Equivalent |
| K082092 | DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE | Oct 15, 2008 | Substantially Equivalent |
| K072755 | GALEMED CPAP MASK | Nov 16, 2007 | Substantially Equivalent |
| K022124 | GALEMED PEAK FLOW METER, MODELS 3751/3752 | Apr 3, 2003 | Substantially Equivalent |
| K021742 | GALEMED NEB-EASY NEBULIZER | Oct 25, 2002 | Substantially Equivalent |