FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FLEXTUBES:9, 20, 26
K Number: K781428
·
Decision Sep 11, 1978
Classifications
1
FEI Numbers
230
Registration Numbers
230
Same Product Code
61
Applicant Total
9
Review Days
21
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Basic Information
- Device Name
- FLEXTUBES:9, 20, 26
- K Number
- K781428
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5860
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Bourns Medical Systems, Inc.
- Date Received
- August 21, 1978
- Decision Date
- September 11, 1978
- Product Code
- BYX
- 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 |
|---|---|---|---|
| BYX | Tubing, Pressure And Accessories | FDA class 1 | Anesthesiology |
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MF CHEMETRON STYLE MEDICAL GAS WALL OUTLETS
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Other Clearances by Bourns Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K802051 | NEWBOURNS INFANT VENTILATOR | Oct 3, 1980 | Substantially Equivalent |
| K802118 | BEAR 2 ADULT VOL. VENTILATOR | Oct 3, 1980 | Substantially Equivalent |
| K801697 | MODEL BP-200 INFANT PRESSURE VENTILATOR | Aug 7, 1980 | Substantially Equivalent |
| K791186 | MODEL BP-2000 TIME-CYCLED VENTILATOR | Jul 6, 1979 | Substantially Equivalent |
| K790199 | VENTILATOR MODEL BV-300 INFANT | Apr 13, 1979 | Substantially Equivalent |
| K781760 | HUMIDIFIERS, MODEL:LS-420 AND LS-460 | Dec 20, 1978 | Substantially Equivalent |
| K781485 | PATIENT CIRCUIT MANIFOLD | Oct 16, 1978 | Substantially Equivalent |
| K781515 | MODEL LS-80 ADULT VENTILATION MONITOR | Oct 2, 1978 | Substantially Equivalent |