FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERCUSSIONAIRE RESPIRATORS (MULTIPLE)
K Number: K884832
·
Decision Sep 14, 1989
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
504
Applicant Total
11
Review Days
300
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Basic Information
- Device Name
- PERCUSSIONAIRE RESPIRATORS (MULTIPLE)
- K Number
- K884832
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Percussionaire Corp.
- Date Received
- November 18, 1988
- Decision Date
- September 14, 1989
- Product Code
- CBK
- 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 |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | FDA class 2 | Anesthesiology |
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Other Clearances by Percussionaire Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K905234 | TXP TRANSPORTER FAMILY AND RELATED ACCESSORIES | Jun 13, 1991 | Substantially Equivalent |
| K905235 | VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESS | May 3, 1991 | Substantially Equivalent |
| K905236 | IPV PERCUSSIONATOR FAMILY & RELATED ACCESSORIES | Apr 18, 1991 | Substantially Equivalent |
| K900315 | PERCUSSIONAIRE TXP TRANSPORTER/RESPIRATORS 750 MIN | Oct 26, 1990 | Substantially Equivalent for Some Indications |
| K900314 | PERCUSSIONAIRE(R) OSCILLATRON-1 PERCUSS 1300 MIN | Oct 26, 1990 | Substantially Equivalent for Some Indications |
| K900313 | PERCUSSIONAIRE(R) VDR-3 IMV PERCUS/RESPIR 1250 MIN | Oct 26, 1990 | Substantially Equivalent |
| K896586 | RATE INCREASE FOR IPPB/IPV | Jan 9, 1990 | Substantially Equivalent |
| K895485 | BIRD (IPV) NONCONTINUOUS VENTILATORS | Oct 30, 1989 | Substantially Equivalent |
| K892886 | PERCUSSIONAIRE OSCILLATRON-1 MEDICAL RESPIRATOR | Oct 27, 1989 | Substantially Equivalent |
| K895486 | BIRD (VDR) SINUSOIDAL PERCUSSIONATORS | Oct 13, 1989 | Substantially Equivalent |