FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LSPI PRESSURE REGULATOR
K Number: K936187
·
Decision Jan 27, 1994
Classifications
1
FEI Numbers
111
Registration Numbers
112
Same Product Code
54
Applicant Total
20
Review Days
35
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Basic Information
- Device Name
- LSPI PRESSURE REGULATOR
- K Number
- K936187
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.2700
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Life Support Products, Inc.
- Date Received
- December 23, 1993
- Decision Date
- January 27, 1994
- Product Code
- CAN
- 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 |
|---|---|---|---|
| CAN | Regulator, Pressure, Gas Cylinder | FDA class 1 | Anesthesiology |
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Other Clearances by Life Support Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K941870 | LSPI AUTOMATIC VENTILATOR, MODEL AV2000-100 | Jan 9, 1995 | Substantially Equivalent |
| K941871 | LSPI AUTOMATIC VENTILATOR, MODEL AV3000-100 | Jan 9, 1995 | Substantially Equivalent |
| K940934 | LIFE VAC | May 3, 1994 | Substantially Equivalent |
| K932200 | LSPI AUTOMATIC VENTILATOR | Nov 24, 1993 | Substantially Equivalent |
| K922819 | INFANT DISPOSABLE BAG MASK RESUSCITATOR | Nov 24, 1993 | Substantially Equivalent |
| K922691 | LSP (MODEL 554) BAG MASK RESUSCITATOR | Nov 24, 1993 | Substantially Equivalent |
| K932199 | LSPI AUTOMATIC VENTILATOR, MODEL AV3000 | Nov 24, 1993 | Substantially Equivalent |
| K921553 | LSPI INFANT BAG MASK | Oct 19, 1992 | Substantially Equivalent |
| K921107 | AUTOVAC | Sep 17, 1992 | Substantially Equivalent |
| K924217 | LSPI DISPOSABLE BAG MASK RESUSCITATOR/MODIFIED | Sep 17, 1992 | Substantially Equivalent |