FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RFS VACUUM GAUGE SCAVENGING CIRCUIT
K Number: K033503
·
Decision Mar 12, 2004
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
42
Applicant Total
5
Review Days
128
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Basic Information
- Device Name
- RFS VACUUM GAUGE SCAVENGING CIRCUIT
- K Number
- K033503
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.5430
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Accutron, Inc.
- Date Received
- November 5, 2003
- Decision Date
- March 12, 2004
- 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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Other Clearances by Accutron, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K052335 | ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA | Nov 23, 2005 | Substantially Equivalent |
| K992421 | GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076 | Oct 27, 1999 | Substantially Equivalent |
| K970046 | UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550) | Mar 28, 1997 | Substantially Equivalent |
| K965239 | PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGING SYSTEM(260-U AND 261-U) | Mar 28, 1997 | Substantially Equivalent |