FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEOPIP PATIENT CIRCUIT WITH PEEP
K Number: K103833
·
Decision Apr 20, 2011
Classifications
1
FEI Numbers
71
Registration Numbers
72
Same Product Code
79
Applicant Total
7
Review Days
111
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Basic Information
- Device Name
- NEOPIP PATIENT CIRCUIT WITH PEEP
- K Number
- K103833
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5965
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neoforce Group, Inc.
- Date Received
- December 30, 2010
- Decision Date
- April 20, 2011
- 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 Neoforce Group, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K110119 | PRESSURE MANOMETER | Jun 10, 2011 | Substantially Equivalent |
| K102649 | NEOPOP INFANT RESUSCITATOR WITH FLOW METER | Jan 6, 2011 | Substantially Equivalent |
| K092085 | ISPIRA RESUSCITATION UNIT | Oct 7, 2009 | Substantially Equivalent |
| K072021 | NEOPIP INFANT RESUSCITATOR | Sep 12, 2007 | Substantially Equivalent |
| K070416 | NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP | May 29, 2007 | Substantially Equivalent |
| K061280 | V-2200 INFANT INCUBATOR | Jun 27, 2006 | Substantially Equivalent |