FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY
K Number: K020700
·
Decision Apr 26, 2004
Classifications
1
FEI Numbers
108
Registration Numbers
108
Same Product Code
220
Applicant Total
12
Review Days
784
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Basic Information
- Device Name
- PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY
- K Number
- K020700
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5450
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pegasus Research Corp.
- Date Received
- March 4, 2002
- Decision Date
- April 26, 2004
- Product Code
- BTT
- 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 |
|---|---|---|---|
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | FDA class 2 | Anesthesiology |
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FDA 510(k)
FDA Class 2
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Other Clearances by Pegasus Research Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K122857 | HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100 | Nov 7, 2012 | Substantially Equivalent |
| K013856 | PMH 1000 HEATED HUMIDIFIER | Feb 21, 2003 | Substantially Equivalent |
| K983783 | HEATED HUMIDIFIER | Oct 24, 2000 | Substantially Equivalent |
| K962534 | THERA-MIST NEBULIZER MODEL-P3000 | Feb 28, 1997 | Substantially Equivalent |
| K946057 | AQUALARM MOISTURE SENSOR MODEL P85000 | May 5, 1995 | Substantially Equivalent |
| K915890 | AUTOCLAVABLE THERA-MIST HUMIDIFIER P3600, MODIFIED | Jun 24, 1992 | Substantially Equivalent |
| K914465 | AUTOCLAVABLE VERSION THERA-MIST NEBULIZER, P32000 | Mar 31, 1992 | Substantially Equivalent |
| K903489 | THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000 | Dec 10, 1990 | Substantially Equivalent |
| K893942 | THERA-MIST(TM) NEBULIZER, MODEL 30000 | Aug 28, 1989 | Substantially Equivalent |
| K894000 | THERA-MIST HUMIDIFIER | Aug 28, 1989 | Substantially Equivalent |