FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
MAC/IV SEDATION KIT
K Number: K935546
·
Decision Jun 13, 1994
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
187
Applicant Total
75
Review Days
208
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Basic Information
- Device Name
- MAC/IV SEDATION KIT
- K Number
- K935546
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5160
- Medical Specialty
- Anesthesiology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Vital Signs, Inc.
- Date Received
- November 17, 1993
- Decision Date
- June 13, 1994
- Product Code
- BSZ
- 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 |
|---|---|---|---|
| BSZ | Gas-Machine, Anesthesia | FDA class 2 | Anesthesiology |
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Other Clearances by Vital Signs, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K112902 | ENFLOW IV FLUID WARMER | Mar 14, 2012 | Substantially Equivalent |
| K041309 | IMASK TM | Jun 30, 2004 | Substantially Equivalent |
| K030985 | BREAS PV 10I CPAP SYSTEM, MODEL PV 10I | Oct 15, 2003 | Substantially Equivalent |
| K022402 | DISPOSABLE PRESSURE MANOMETER | Aug 22, 2002 | Substantially Equivalent |
| K021315 | SURE-LOK | Aug 21, 2002 | Substantially Equivalent |
| K002454 | BREAS HA50 HUMIDIFIER, MODEL HA50 | Mar 7, 2001 | Substantially Equivalent |
| K001553 | BREAS PV 100 CPAP SYSTEM | Aug 3, 2000 | Substantially Equivalent |
| K000441 | BODYGUARD | Apr 11, 2000 | Substantially Equivalent |
| K994044 | CLEEN-ABLE | Feb 25, 2000 | Substantially Equivalent |
| K990412 | CUFF-ABLE PLUS | Sep 1, 1999 | Substantially Equivalent |