FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PURITAN-BENNETT OXYGEN PRESSURE REGULATOR
K Number: K896128
·
Decision Jan 9, 1990
Classifications
1
FEI Numbers
111
Registration Numbers
112
Same Product Code
54
Applicant Total
110
Review Days
78
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Basic Information
- Device Name
- PURITAN-BENNETT OXYGEN PRESSURE REGULATOR
- K Number
- K896128
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.2700
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Puritan Bennett Corp.
- Date Received
- October 23, 1989
- Decision Date
- January 9, 1990
- Product Code
- CAN
- 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 |
|---|---|---|---|
| CAN | Regulator, Pressure, Gas Cylinder | FDA class 1 | Anesthesiology |
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|---|---|---|---|
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| K022103 | PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM | Sep 27, 2002 | Substantially Equivalent |
| 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. |