FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RESUSCITATOR
K Number: K874567
·
Decision Feb 29, 1988
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
208
Applicant Total
6
Review Days
116
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Basic Information
- Device Name
- RESUSCITATOR
- K Number
- K874567
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5915
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- American Medical Technology, Inc.
- Date Received
- November 5, 1987
- Decision Date
- February 29, 1988
- Product Code
- BTM
- 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 |
|---|---|---|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | FDA class 2 | Anesthesiology |
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FDA 510(k)
FDA Class 2
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Other Clearances by American Medical Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K963808 | CHOICE POWERED WHEELCHAIR | Feb 12, 1997 | Substantially Equivalent |
| K905745 | AMETEC MASY MODULAR ANGIOSCOPE SYSTEM | Apr 23, 1992 | Substantially Equivalent |
| K874430 | NEEDLE CONTAINER | Jan 4, 1988 | Substantially Equivalent |
| K874360 | PLASTIC TUBING CONNECTOR | Nov 17, 1987 | Substantially Equivalent |
| K873313 | SURGICAL DRAPE | Sep 4, 1987 | Substantially Equivalent |