FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE PURITAN-BENNETT 318 PLUS NASAL CPAP SYSTEM
K Number: K960518
·
Decision May 9, 1996
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
449
Applicant Total
110
Review Days
94
Basic Information
- Device Name
- THE PURITAN-BENNETT 318 PLUS NASAL CPAP SYSTEM
- K Number
- K960518
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5905
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PURITAN BENNETT CORP.
- Date Received
- February 5, 1996
- Decision Date
- May 9, 1996
- Product Code
- BZD
- 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 |
|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | FDA class 2 | Anesthesiology |
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Other Clearances by PURITAN BENNETT CORP.
| K Number | Device Name | ||
|---|---|---|---|
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| 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. |