FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRANSONIC FLOWMETER
K Number: K872048
·
Decision Jun 21, 1988
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
136
Applicant Total
16
Review Days
390
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Basic Information
- Device Name
- TRANSONIC FLOWMETER
- K Number
- K872048
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Transonic Systems, Inc.
- Date Received
- May 28, 1987
- Decision Date
- June 21, 1988
- Product Code
- DPW
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| K113821 | TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM | Sep 7, 2012 | Substantially Equivalent |
| K112657 | AUREFLO MONITORING SYSTEM | Dec 21, 2011 | Substantially Equivalent |
| K080116 | TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM | Sep 8, 2008 | Substantially Equivalent |
| K033424 | ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002 | Dec 11, 2003 | Substantially Equivalent |
| K022963 | TRANSONIC SYRINGE WARMER, MODEL SYR-1000 | Dec 4, 2002 | Substantially Equivalent |
| K021571 | TRANSONIC FLOW-QC SET MODEL ADT1010 | Aug 12, 2002 | Substantially Equivalent |