FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AEROCHAMBER
K Number: K872037
·
Decision Jul 24, 1987
Classifications
1
FEI Numbers
162
Registration Numbers
162
Same Product Code
24
Applicant Total
33
Review Days
58
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Basic Information
- Device Name
- AEROCHAMBER
- K Number
- K872037
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5620
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Monaghan Medical Corp.
- Date Received
- May 27, 1987
- Decision Date
- July 24, 1987
- Product Code
- BYP
- 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 |
|---|---|---|---|
| BYP | Mouthpiece, Breathing | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BYP), ordered by most recent decision date.
NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE
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TRUZONE PFM DISPOSABLE MOUTHPIECE
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BREATHING MOUTHPIECE
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SAFE-T-SHIELD MOUTHPIECE
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INHALATION AID
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FDA Class 1
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MP-4400 MOUTHPIECE-FLANGE SEAL
FDA 510(k)
FDA Class 1
·Anesthesiology
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 |
| K955262 | TRUZONE PEAK FLOW METER | Mar 7, 1996 | Substantially Equivalent |