FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AIR SHIELDS AS461 MONITORING SYS
K Number: K842321
·
Decision Aug 3, 1984
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
338
Applicant Total
33
Review Days
52
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Basic Information
- Device Name
- AIR SHIELDS AS461 MONITORING SYS
- K Number
- K842321
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Air-Shields, Inc.
- Date Received
- June 12, 1984
- Decision Date
- August 3, 1984
- Product Code
- DRT
- 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 |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | FDA class 2 | Cardiovascular |
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| K940951 | RW RESUCITAIRE INFANT RADIANT WARMER | May 3, 1995 | Substantially Equivalent |
| K940975 | C450/C400 INFANT INCUBATORS | Jun 23, 1994 | Substantially Equivalent |
| K941106 | MODEL TI500 ISOLETTE INFANT INCUBATOR | Jun 10, 1994 | Substantially Equivalent |
| K924170 | ISOLETTE INCUBATOR HUMIDITY METER | Feb 5, 1993 | Substantially Equivalent |
| K922150 | EXAMINATION LAMP | Jul 21, 1992 | Substantially Equivalent |