FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SERIES D FLOWMETER
K Number: K872718
·
Decision Aug 5, 1987
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
23
Applicant Total
110
Review Days
26
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Basic Information
- Device Name
- SERIES D FLOWMETER
- K Number
- K872718
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.2340
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Puritan Bennett Corp.
- Date Received
- July 10, 1987
- Decision Date
- August 5, 1987
- Product Code
- CAX
- 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 |
|---|---|---|---|
| CAX | Flowmeter, Tube, Thorpe, Back-Pressure Compensated | FDA class 1 | Anesthesiology |
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|---|---|---|---|
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| K001646 | PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION | Oct 20, 2000 | Substantially Equivalent - Subject to Tracking Reg. |
| K002001 | BREEZE SLEEPGEAR WITH DREAMSEAL | Sep 6, 2000 | Substantially Equivalent |
| K993071 | PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC, OPTION, MODEL 840 | Nov 24, 1999 | Substantially Equivalent - Subject to Tracking Reg. |
| K993220 | PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM | Oct 22, 1999 | Substantially Equivalent |
| K993088 | PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCI | Oct 8, 1999 | Substantially Equivalent |
| K984535 | PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION | Dec 28, 1998 | Substantially Equivalent - Subject to Tracking Reg. |