FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRUZONE PEAK FLOW METER
K Number: K955262
·
Decision Mar 7, 1996
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
79
Applicant Total
33
Review Days
114
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Basic Information
- Device Name
- TRUZONE PEAK FLOW METER
- K Number
- K955262
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1860
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Monaghan Medical Corp.
- Date Received
- November 14, 1995
- Decision Date
- March 7, 1996
- Product Code
- BZH
- 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 |
|---|---|---|---|
| BZH | Meter, Peak Flow, Spirometry | FDA class 2 | Anesthesiology |
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Other Clearances by Monaghan Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K123945 | STRIVE DUAL ZONE PEAK FLOW METER | Apr 17, 2013 | Substantially Equivalent |
| K031514 | MODIFICATION TO TRUPEAK PEAK FLOW METER | May 23, 2003 | Substantially Equivalent |
| K023097 | TRUEZONE PEAK FLOW METER | Mar 7, 2003 | Substantially Equivalent |
| K012939 | AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER | Sep 28, 2001 | Substantially Equivalent |
| K991212 | MODIFICATION TO TRUZONE PEAK FLOW METER | Jul 1, 1999 | Substantially Equivalent |
| K964130 | AEROGEAR ASTHMA ACTION KIT | Jan 10, 1997 | Substantially Equivalent |
| K963089 | TRUZONE PEAK FLOW METER | Nov 6, 1996 | Substantially Equivalent |
| K963095 | TRUPEAK PEAK FLOW METER | Nov 4, 1996 | Substantially Equivalent |
| K955234 | TRUPEAK PEAK FLOW METER | Mar 18, 1996 | Substantially Equivalent |
| K944512 | TRUZONE PFM DISPOSABLE MOUTHPIECE | Nov 2, 1994 | Substantially Equivalent |