FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BABYSET(TM) MODIFIED JACKSON-REES CIRCUIT W/VALVE
K Number: K871669
·
Decision May 19, 1987
Classifications
1
FEI Numbers
199
Registration Numbers
199
Same Product Code
183
Applicant Total
29
Review Days
21
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Basic Information
- Device Name
- BABYSET(TM) MODIFIED JACKSON-REES CIRCUIT W/VALVE
- K Number
- K871669
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5240
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Life Design Systems, Inc.
- Date Received
- April 28, 1987
- Decision Date
- May 19, 1987
- 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 |
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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 |
| K873179 | HEATER WIRE BREATHING CIRCUIT | Mar 31, 1988 | Substantially Equivalent |