FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIFE-02 (NON-REFILLABLE CYLINDER)
K Number: K910699
·
Decision Jun 18, 1991
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
99
Applicant Total
5
Review Days
119
Basic Information
- Device Name
- LIFE-02 (NON-REFILLABLE CYLINDER)
- K Number
- K910699
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5925
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- LIFE CORP.
- Date Received
- February 19, 1991
- Decision Date
- June 18, 1991
- Product Code
- BTL
- 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 |
|---|---|---|---|
| BTL | Ventilator, Emergency, Powered (Resuscitator) | FDA class 2 | Anesthesiology |
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Other Clearances by LIFE CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K910435 | LIFE OXYGENPAC 6/12 LPM | Jun 17, 1991 | Substantially Equivalent |
| K910434 | LIFE OXYGENPAC FOR TRAINED MEDICAL PERSONNEL | Jun 17, 1991 | Substantially Equivalent |
| K910201 | LIFE O2 | Feb 1, 1991 | Substantially Equivalent |
| K855092 | LIFE CORP. OXYGEN PAC | Jan 21, 1986 | Substantially Equivalent |