FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CIRCUIT GUARD
K Number: K982239
·
Decision Aug 14, 1998
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
201
Applicant Total
6
Review Days
52
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Basic Information
- Device Name
- CIRCUIT GUARD
- K Number
- K982239
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5260
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arc Medical, Inc.
- Date Received
- June 23, 1998
- Decision Date
- August 14, 1998
- Product Code
- CAH
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| CAH | Filter, Bacterial, Breathing-Circuit | FDA class 2 | Anesthesiology |
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Other Clearances by Arc Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K090738 | THERMOFLO HCH, THERMOFLO FILTER | Jul 27, 2009 | Substantially Equivalent |
| K063125 | FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME) | Apr 13, 2007 | Substantially Equivalent |
| K011212 | FILTERFLO H | Dec 20, 2001 | Substantially Equivalent |
| K924997 | EDD | Mar 28, 1995 | Substantially Equivalent |
| K924627 | XTEND CIRCUITS (TM) | Apr 7, 1993 | Substantially Equivalent |