FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MERCURY CPAP
K Number: K090710
·
Decision Aug 20, 2009
Classifications
1
FEI Numbers
71
Registration Numbers
72
Same Product Code
79
Applicant Total
15
Review Days
155
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Basic Information
- Device Name
- MERCURY CPAP
- K Number
- K090710
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5965
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mercury Medical
- Date Received
- March 18, 2009
- Decision Date
- August 20, 2009
- 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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|---|---|---|---|
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| K032593 | MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER | Feb 3, 2004 | Substantially Equivalent |
| K031814 | STATCO2METER, MODEL 10-55372 | Aug 14, 2003 | Substantially Equivalent |
| K031411 | MINI STATCO2 CO2 DETECTOR, MODEL 10-55371 | Jul 30, 2003 | Substantially Equivalent |
| K021576 | MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370 | Nov 4, 2002 | Substantially Equivalent |
| K001714 | MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149 | Nov 3, 2000 | Substantially Equivalent |
| K000073 | MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA | Mar 1, 2000 | Substantially Equivalent |
| K970756 | MERCURY MEDICAL REUSABLE CPR BAG | Oct 31, 1997 | Substantially Equivalent |
| K954492 | MERCURY MEDICAL EXPIRATORY RESISTANCE EXERCISER, RESISTEX | Oct 21, 1996 | Substantially Equivalent |