FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BUNN VOLUMAIRE RESPIRATORY EXERCISER
K Number: K800546
·
Decision Mar 25, 1980
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
107
Applicant Total
20
Review Days
15
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Basic Information
- Device Name
- BUNN VOLUMAIRE RESPIRATORY EXERCISER
- K Number
- K800546
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5690
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- The John Bunn Co.
- Date Received
- March 10, 1980
- Decision Date
- March 25, 1980
- Product Code
- BWF
- 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 |
|---|---|---|---|
| BWF | Spirometer, Therapeutic (Incentive) | FDA class 2 | Anesthesiology |
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Other Clearances by The John Bunn Co.
| K Number | Device Name | ||
|---|---|---|---|
| K900854 | JOHN BUNN: MEDIX COMPACT TRAVELLER | Apr 23, 1990 | Substantially Equivalent |
| K883216 | BUNN MODEL 50 OXYGEN FLOW CONTROLLER | Aug 18, 1988 | Substantially Equivalent |
| K873071 | BUNN CONCENTRATOR MODEL 2100 SERIES | Sep 15, 1987 | Substantially Equivalent |
| K870094 | BUNN MODEL 530 ASPIRATOR | Mar 6, 1987 | Substantially Equivalent |
| K861435 | BUNN CONCENTRATOR MODEL 2011 WITH DEMAND VALVE | Nov 7, 1986 | Substantially Equivalent |
| K861199 | BUNN MODEL 22 OXYGEN FLOW CONTROLLER | Aug 26, 1986 | Substantially Equivalent |
| K862628 | BUNN MODEL 510 MEDICATION COMPRESSOR | Aug 7, 1986 | Substantially Equivalent |
| K855208 | BUNN LITE OXYGEN CONCENTRATOR | Feb 21, 1986 | Substantially Equivalent |
| K860060 | RX02 PLUS OXYGEN CONCENTRATOR | Feb 5, 1986 | Substantially Equivalent |
| K843811 | BUNN 3001 OXYGEN CONCENTRATOR | Oct 4, 1984 | Substantially Equivalent |