FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ANESTHESIA BREATHING CIRCUITS
K Number: K830470
·
Decision Mar 24, 1983
Classifications
1
FEI Numbers
199
Registration Numbers
199
Same Product Code
183
Applicant Total
17
Review Days
37
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Basic Information
- Device Name
- ANESTHESIA BREATHING CIRCUITS
- K Number
- K830470
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5240
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Mon-A-Therm, Inc.
- Date Received
- February 15, 1983
- Decision Date
- March 24, 1983
- Product Code
- CAI
- 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 |
|---|---|---|---|
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
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Other Clearances by Mon-A-Therm, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K885187 | MODEL 1000 ELECTRONIC CLINICAL THERMOMETER | Mar 8, 1989 | Substantially Equivalent |
| K874522 | MODIFIED MYOCARDIAL TEMPERATURE SENSOR | Jan 29, 1988 | Substantially Equivalent |
| K874519 | MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR | Jan 29, 1988 | Substantially Equivalent |
| K875234 | MON-A-THERM'S SKIN TEMPERATURE SENSOR | Jan 19, 1988 | Substantially Equivalent |
| K874525 | MODIFIED FOLEY CATHETER/TEMPERATURE SENSOR | Jan 6, 1988 | Substantially Equivalent |
| K874524 | MODIFIED SUBCUTANEOUS TEMPERATURE SENSOR | Jan 6, 1988 | Substantially Equivalent |
| K874523 | MODIFIED TYMPANIC & ESOPHAGEAL/RECTAL TEMP. SENSOR | Jan 6, 1988 | Substantially Equivalent |
| K874521 | MODIFIED THERMAL WELL TEMPERATURE SENSOR | Jan 6, 1988 | Substantially Equivalent |
| K874520 | MODIFIED AIRWAY TEMPERATURE SENSOR | Jan 6, 1988 | Substantially Equivalent |
| K853392 | MON-A-THERM SUBCUTANEOUS TEMP. SENSOR | Nov 22, 1985 | Substantially Equivalent |