FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
XOMED PATENCY MONITOR
K Number: K821373
·
Decision Jul 8, 1982
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
136
Applicant Total
82
Review Days
59
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Basic Information
- Device Name
- XOMED PATENCY MONITOR
- K Number
- K821373
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Xomed, Inc.
- Date Received
- May 10, 1982
- Decision Date
- July 8, 1982
- Product Code
- DPW
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| K993582 | MODIFICATION TO LASER-SHIELD II | Jan 20, 2000 | Substantially Equivalent |
| K993655 | MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS | Dec 21, 1999 | Substantially Equivalent |