FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PALL HEAT MOISTURE EXCHANGING FILTER
K Number: K834292
·
Decision Apr 4, 1984
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
72
Applicant Total
28
Review Days
118
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Basic Information
- Device Name
- PALL HEAT MOISTURE EXCHANGING FILTER
- K Number
- K834292
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Pall Biomedical Products Co.
- Date Received
- December 8, 1983
- Decision Date
- April 4, 1984
- Product Code
- BYD
- 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 |
|---|---|---|---|
| BYD | Condenser, Heat And Moisture (Artificial Nose) | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BYD), ordered by most recent decision date.
HEAT & MOISTURE EXCHANGER
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DISPOSABLE HME/FILTER
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HEAT MOISTURE EXCHANGER
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TYPE 1 & 2 (HUMIDAIR I & II)
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HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT
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HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Pall Biomedical Products Co.
| K Number | Device Name | ||
|---|---|---|---|
| K954331 | PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) | Jan 9, 1997 | Substantially Equivalent |
| K960993 | PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST) | Apr 22, 1996 | Substantially Equivalent |
| K905794 | PALL 3N1 FILTER | Jun 13, 1991 | Substantially Equivalent |
| K902518 | LD-SIX ARTERIAL BLOOD FILTER FOR EXTRA. SERVICE | Oct 16, 1990 | Substantially Equivalent |
| K884534 | PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER | Jan 24, 1989 | Substantially Equivalent |
| K875095 | PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE | Feb 29, 1988 | Substantially Equivalent |
| K875094 | ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE | Feb 29, 1988 | Substantially Equivalent |
| K873667 | PALL LEUKOCYTE REMOVAL FILTER, PLATELETS | Jan 6, 1988 | Substantially Equivalent |
| K873666 | PALL LEUKOCYTE REMOVAL FILTER, BLOOD | Jan 6, 1988 | Substantially Equivalent |
| K874405 | PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE | Dec 30, 1987 | Substantially Equivalent |