FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ISPIRA RESUSCITATION UNIT
K Number: K092085
·
Decision Oct 7, 2009
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
99
Applicant Total
7
Review Days
90
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Basic Information
- Device Name
- ISPIRA RESUSCITATION UNIT
- K Number
- K092085
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5925
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neoforce Group, Inc.
- Date Received
- July 9, 2009
- Decision Date
- October 7, 2009
- Product Code
- BTL
- 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 |
|---|---|---|---|
| BTL | Ventilator, Emergency, Powered (Resuscitator) | 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 |
| K103833 | NEOPIP PATIENT CIRCUIT WITH PEEP | Apr 20, 2011 | Substantially Equivalent |
| K102649 | NEOPOP INFANT RESUSCITATOR WITH FLOW METER | Jan 6, 2011 | 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 |