FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
REGULATOR OXYGEN MECHANICAL
K Number: K863711
·
Decision Jan 27, 1987
Classifications
1
FEI Numbers
111
Registration Numbers
112
Same Product Code
54
Applicant Total
12
Review Days
126
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Basic Information
- Device Name
- REGULATOR OXYGEN MECHANICAL
- K Number
- K863711
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.2700
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Lifeguard Medical Products, Inc.
- Date Received
- September 23, 1986
- Decision Date
- January 27, 1987
- 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 Lifeguard Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K013421 | LIFEGUARD NASAL CPAP MASK AND ACCESSORIES | Jan 8, 2002 | Substantially Equivalent |
| K915296 | MONOPOLAR ELECTRODE | Sep 3, 1992 | Substantially Equivalent |
| K920471 | LEVY ARTICULATING RETRACTOR | Jun 23, 1992 | Substantially Equivalent |
| K915505 | REGULATOR FLOWMETER | Apr 22, 1992 | Substantially Equivalent |
| K915297 | TROCAR & TROCAR SLEEEVE 11MM, 10MM, 8MM & 5MM | Feb 11, 1992 | Substantially Equivalent |
| K915298 | SUCTION/IRRIGATION CANNULA; CATLOG #532.00 | Jan 23, 1992 | Substantially Equivalent |
| K880958 | LIFEGUARD BACTERIAL AND VIRAL FILTER | Apr 27, 1988 | Substantially Equivalent |
| K880959 | LIFEGUARD GAS SAMPLING LINE FOR MASS SPECTROMETRY | Apr 14, 1988 | Substantially Equivalent |
| K881087 | LIFEGUARD SINGLE USE MANUAL RESUSCITATORS | Apr 14, 1988 | Substantially Equivalent |
| K881086 | LIFEGUARD MOUTH TO MASK RESUSCITATOR | Apr 14, 1988 | Substantially Equivalent |