FDA 510(k)
Substantially Equivalent
🇺🇸 United States
MA-2 AND MA2+2 VOLUME VENTILATORS
K Number: K864430
·
Decision Jan 15, 1987
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
110
Review Days
64
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Basic Information
- Device Name
- MA-2 AND MA2+2 VOLUME VENTILATORS
- K Number
- K864430
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Puritan Bennett Corp.
- Date Received
- November 12, 1986
- Decision Date
- January 15, 1987
- Advisory Committee
- Unknown
- Review Advisory Committee
- AN
- Third Party
- N
Other Clearances by Puritan Bennett Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K063650 | VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840 | Feb 15, 2007 | Substantially Equivalent |
| K053388 | MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION | Apr 4, 2006 | Substantially Equivalent |
| K023225 | PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE | Dec 18, 2002 | Substantially Equivalent |
| 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. |