FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RESPIREX 2
K Number: K900754
·
Decision Mar 15, 1990
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
106
Applicant Total
12
Review Days
27
Basic Information
- Device Name
- RESPIREX 2
- K Number
- K900754
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5690
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- DIEMOLDING CORP.
- Date Received
- February 16, 1990
- Decision Date
- March 15, 1990
- Product Code
- BWF
- 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 |
|---|---|---|---|
| BWF | Spirometer, Therapeutic (Incentive) | FDA class 2 | Anesthesiology |
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| K Number | Device Name | ||
|---|---|---|---|
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| K902114 | CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR | Jul 18, 1990 | Substantially Equivalent |
| K893791 | BREATHING MOUTHPIECE | Jun 23, 1989 | Substantially Equivalent |
| K781759 | RESCAL | Nov 27, 1978 | Substantially Equivalent |
| K780750 | O2 CONNECTOR | Jul 27, 1978 | Substantially Equivalent |
| K770369 | VACON TM | Mar 1, 1977 | Substantially Equivalent |
| K760931 | I.V. DRIP MONITOR ALARM DEVICE, MONIFLO | Jan 5, 1977 | Substantially Equivalent |
| K760636 | ORTHOMIX | Oct 5, 1976 | Substantially Equivalent |