FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE
K Number: K023225
·
Decision Dec 18, 2002
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
227
Applicant Total
110
Review Days
82
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Basic Information
- Device Name
- PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE
- K Number
- K023225
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 868.1840
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Puritan Bennett Corp.
- Date Received
- September 27, 2002
- Decision Date
- December 18, 2002
- Product Code
- BZG
- 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 |
|---|---|---|---|
| BZG | Spirometer, Diagnostic | FDA class 2 | Anesthesiology |
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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 |
| 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. |
| K984379 | NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEM | Dec 10, 1998 | Substantially Equivalent |