FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACCUFLATE ACCESSORIE CART W/IV POLE AND CLAMP
K Number: K924373
·
Decision Nov 25, 1992
Classifications
1
FEI Numbers
135
Registration Numbers
135
Same Product Code
7
Applicant Total
7
Review Days
89
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Basic Information
- Device Name
- ACCUFLATE ACCESSORIE CART W/IV POLE AND CLAMP
- K Number
- K924373
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.6175
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Instrumed, Inc.
- Date Received
- August 28, 1992
- Decision Date
- November 25, 1992
- Product Code
- BZN
- 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 |
|---|---|---|---|
| BZN | Cart, Emergency, Cardiopulmonary (Excluding Equipment) | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
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Other Clearances by Instrumed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K952038 | CLEAN-CUFF | Jul 11, 1995 | Substantially Equivalent |
| K940615 | ACCUTEST | May 19, 1995 | Substantially Equivalent |
| K924273 | ACCUFLATE | Jan 12, 1993 | Substantially Equivalent |
| K910512 | ACCUFLATE | Feb 19, 1991 | Substantially Equivalent |
| K890014 | DISPOSABLE COLOR-CUFFS | Jan 24, 1989 | Substantially Equivalent |
| K860617 | POLYPET | Mar 3, 1986 | Substantially Equivalent |