FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AUTOMATIC VACUUM SWITCH (AVS) MODEL NUMBER AVS 5000
K Number: K981754
·
Decision Jun 16, 1998
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
42
Applicant Total
6
Review Days
29
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Basic Information
- Device Name
- AUTOMATIC VACUUM SWITCH (AVS) MODEL NUMBER AVS 5000
- K Number
- K981754
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.5430
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Porter Instrument Co., Inc.
- Date Received
- May 18, 1998
- Decision Date
- June 16, 1998
- Product Code
- CBN
- 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 |
|---|---|---|---|
| CBN | Apparatus, Gas-Scavenging | FDA class 2 | Anesthesiology |
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