FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THE INFANT FLOW SYSTEM
K Number: K930713
·
Decision Sep 16, 1993
Classifications
1
FEI Numbers
199
Registration Numbers
199
Same Product Code
183
Applicant Total
23
Review Days
217
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Basic Information
- Device Name
- THE INFANT FLOW SYSTEM
- K Number
- K930713
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5240
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sechrist Industries, Inc.
- Date Received
- February 11, 1993
- Decision Date
- September 16, 1993
- Product Code
- CAI
- 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 |
|---|---|---|---|
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | FDA class 1 | Anesthesiology |
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| K Number | Device Name | ||
|---|---|---|---|
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| 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 |
| K914607 | SEHRIST VOLUME VENTILATOR, MODEL 2200B | Nov 2, 1992 | Substantially Equivalent |
| K896269 | SECHRIST VOLUME VENTILATOR MODEL 2200B | May 18, 1990 | Substantially Equivalent |