FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INTERMED, INS STERILE WATER/SALINE
K Number: K842166
·
Decision Feb 12, 1985
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
115
Applicant Total
16
Review Days
257
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Basic Information
- Device Name
- INTERMED, INS STERILE WATER/SALINE
- K Number
- K842166
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.6810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Intermed, Inc.
- Date Received
- May 31, 1984
- Decision Date
- February 12, 1985
- Product Code
- BSY
- 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 |
|---|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | FDA class 1 | Anesthesiology |
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Other Clearances by Intermed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K900857 | NON STERILE PARENTERAL SUPPLY KIT | May 22, 1990 | Unknown |
| K833126 | DRESSING CHANGE TRAYS | Jan 27, 1984 | Substantially Equivalent |
| K833574 | PERCUTANEOUS SHEATH INTRODUCER TRAYS | Jan 11, 1984 | Substantially Equivalent |
| K833573 | CENTRAL VEIN CATH. TRAY CC-20-1420 | Jan 11, 1984 | Substantially Equivalent |
| K833139 | ACUTE HEMODIALYSIS TRAYS | Dec 22, 1983 | Substantially Equivalent |
| K833059 | SUCTION CATHETER TRAYS | Dec 12, 1983 | Substantially Equivalent |
| K821269 | TRACHEOSTOMY CARE TRAYS | May 27, 1982 | Substantially Equivalent |
| K791427 | CATHETERIZATION TRAYS FOLEY AND URETHRAL | Sep 7, 1979 | Substantially Equivalent |
| K791426 | PERITONEAL PAC | Aug 28, 1979 | Substantially Equivalent |
| K781748 | IRRIGATION TRAY | Dec 12, 1978 | Substantially Equivalent |