FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LIFEGUARD GAS SAMPLING LINE FOR MASS SPECTROMETRY
K Number: K880959
·
Decision Apr 14, 1988
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
87
Applicant Total
12
Review Days
38
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Basic Information
- Device Name
- LIFEGUARD GAS SAMPLING LINE FOR MASS SPECTROMETRY
- K Number
- K880959
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5975
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Lifeguard Medical Products, Inc.
- Date Received
- March 7, 1988
- Decision Date
- April 14, 1988
- Product Code
- BZO
- 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 |
|---|---|---|---|
| BZO | Set, Tubing And Support, Ventilator (W Harness) | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZO), ordered by most recent decision date.
UNICOR, INC. CORRUGATED TUBING
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FDA Class 1
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UNICOR, INC. VENTILATOR HOSES
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FDA Class 1
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PRIMA VENTILATOR HOSES
FDA 510(k)
FDA Class 1
·Anesthesiology
PRIMA CUSTOM ANESTESIA CIRCUIT
FDA 510(k)
FDA Class 1
·Anesthesiology
PRIMA BREATHING BAGS
FDA 510(k)
FDA Class 1
·Anesthesiology
PRIMA VOLUMN VENTILATORSS
FDA 510(k)
FDA Class 1
·Anesthesiology
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 |
| K881087 | LIFEGUARD SINGLE USE MANUAL RESUSCITATORS | Apr 14, 1988 | Substantially Equivalent |
| K881086 | LIFEGUARD MOUTH TO MASK RESUSCITATOR | Apr 14, 1988 | Substantially Equivalent |
| K863711 | REGULATOR OXYGEN MECHANICAL | Jan 27, 1987 | Substantially Equivalent |