FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEATER WIRE BREATHING CIRCUIT
K Number: K873179
·
Decision Mar 31, 1988
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
45
Applicant Total
29
Review Days
232
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Basic Information
- Device Name
- HEATER WIRE BREATHING CIRCUIT
- K Number
- K873179
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5270
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Life Design Systems, Inc.
- Date Received
- August 12, 1987
- Decision Date
- March 31, 1988
- Product Code
- BZE
- 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 |
|---|---|---|---|
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZE), ordered by most recent decision date.
inspired Heated Breathing Circuit (510-008); inspired Heated Breathing Circuit (510-009); inspired Auto-feed Humidification Chamber (VHC10); inspired Auto-feed Humidification Chamber (VHC20)
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Other Clearances by Life Design Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K913714 | MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM) | Dec 1, 1992 | Substantially Equivalent |
| K885313 | HUMIDI-FLEX TM | Oct 11, 1989 | Substantially Equivalent |
| K893030 | CHILD SIZE - FILTER FLEX (TM) | Sep 18, 1989 | Substantially Equivalent |
| K892862 | FLEX-CUP PERCUSSOR | May 25, 1989 | Substantially Equivalent |
| K892221 | PULMONARY RESUSCITATOR, MODIFICATION | May 18, 1989 | Substantially Equivalent |
| K890011 | OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING | Mar 20, 1989 | Substantially Equivalent |
| K890108 | MODIFIED CUSHION-FLEX(TM) | Jan 24, 1989 | Substantially Equivalent |
| K884387 | CUSHION FLEX(TM) | Nov 17, 1988 | Substantially Equivalent |
| K884068 | PULMANEX TM (NEO-NATAL SIZE) | Nov 16, 1988 | Substantially Equivalent |
| K863857 | PULSE-OX | Oct 7, 1987 | Substantially Equivalent |