FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LSP MINILATOR
K Number: K860516
·
Decision Feb 21, 1986
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
6
Applicant Total
20
Review Days
10
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Basic Information
- Device Name
- LSP MINILATOR
- K Number
- K860516
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.2350
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Life Support Products, Inc.
- Date Received
- February 11, 1986
- Decision Date
- February 21, 1986
- Product Code
- BXY
- 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 |
|---|---|---|---|
| BXY | Flowmeter, Calibration, Gas | 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 |
| K936187 | LSPI PRESSURE REGULATOR | Jan 27, 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 |