FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VOLUME VENTILATOR
K Number: K832508
·
Decision Dec 27, 1983
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
504
Applicant Total
23
Review Days
153
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Basic Information
- Device Name
- VOLUME VENTILATOR
- K Number
- K832508
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Sechrist Industries, Inc.
- Date Received
- July 27, 1983
- Decision Date
- December 27, 1983
- Product Code
- CBK
- 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 |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | FDA class 2 | Anesthesiology |
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Other Clearances by Sechrist Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K140559 | SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER | May 30, 2014 | Substantially Equivalent |
| K100268 | SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER | Apr 26, 2010 | Substantially Equivalent |
| K052713 | MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER | Oct 28, 2005 | Substantially Equivalent |
| K023745 | SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G | Jan 17, 2003 | Substantially Equivalent |
| K993167 | MILLENNIUM INFANT VENTILATOR | Nov 10, 1999 | Substantially Equivalent - Subject to Tracking Reg. |
| K992503 | SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIES | Aug 10, 1999 | Substantially Equivalent |
| K934164 | MODEL 2500E/2500ER HYPERBARIC CHAMBER | Jun 13, 1995 | Substantially Equivalent |
| K950386 | MODEL 3200P/3200PR HYPERBARIC CHAMBER | Jun 13, 1995 | Substantially Equivalent |
| K930713 | THE INFANT FLOW SYSTEM | Sep 16, 1993 | Substantially Equivalent |
| K914607 | SEHRIST VOLUME VENTILATOR, MODEL 2200B | Nov 2, 1992 | Substantially Equivalent |