FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
DEVILBISS MODEL 7427D
K Number: K913316
·
Decision Dec 11, 1991
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
507
Applicant Total
29
Review Days
140
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Basic Information
- Device Name
- DEVILBISS MODEL 7427D
- K Number
- K913316
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Devilbiss Health Care, Inc.
- Date Received
- July 24, 1991
- Decision Date
- December 11, 1991
- Product Code
- CAF
- 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 |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | FDA class 2 | Anesthesiology |
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Other Clearances by Devilbiss Health Care, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K963349 | DEVILBISS 8650D | Jun 13, 1997 | Substantially Equivalent |
| K970289 | COMPRESSOR/NEBULIZER #3650 | Apr 15, 1997 | Substantially Equivalent |
| K961126 | PULSE DOSE SERIES | Oct 21, 1996 | Substantially Equivalent |
| K950849 | MODEL #7354 | Feb 8, 1996 | Substantially Equivalent |
| K952491 | MODEL 7355 | Jan 31, 1996 | Substantially Equivalent |
| K952249 | JET NEBULIZER | Jan 30, 1996 | Substantially Equivalent |
| K953815 | 5 LPM OXYGEN CONCENTRATOR | Nov 9, 1995 | Substantially Equivalent |
| K952037 | 3 LPM OXYGEN CONCENTRATOR | Sep 6, 1995 | Substantially Equivalent |
| K946095 | DEVILBISS MODEL 5500 | Aug 24, 1995 | Substantially Equivalent |
| K944611 | MODEL# 7500 SURVEYOR | Apr 21, 1995 | Substantially Equivalent |