FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INFAGUARD TM
K Number: K854705
·
Decision May 1, 1986
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
174
Applicant Total
3
Review Days
161
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Basic Information
- Device Name
- INFAGUARD TM
- K Number
- K854705
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Lifewatch Systems, Inc.
- Date Received
- November 21, 1985
- Decision Date
- May 1, 1986
- Product Code
- BZQ
- 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 |
|---|---|---|---|
| BZQ | Monitor, Breathing Frequency | FDA class 2 | Anesthesiology |
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