FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REMREST
K Number: K002763
·
Decision May 4, 2001
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
459
Applicant Total
19
Review Days
241
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Basic Information
- Device Name
- REMREST
- K Number
- K002763
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5905
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medical Industries America, Inc.
- Date Received
- September 5, 2000
- Decision Date
- May 4, 2001
- Product Code
- BZD
- 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 |
|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | FDA class 2 | Anesthesiology |
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Other Clearances by Medical Industries America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K050990 | REMREST HEATED HUMIDIFIER | May 2, 2005 | Substantially Equivalent |
| K032170 | TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000 | May 28, 2004 | Substantially Equivalent |
| K011053 | OPTIMA | Apr 20, 2001 | Substantially Equivalent |
| K964078 | 3050 SPORT-NEB | Jan 10, 1997 | Substantially Equivalent |
| K943990 | 3000 AEROSOL TWO | Mar 21, 1995 | Substantially Equivalent |
| K942444 | 3002 AEROMAX | Mar 10, 1995 | Substantially Equivalent |
| K941961 | 605 VACU-MAX | Mar 2, 1995 | Substantially Equivalent |
| K942208 | 4003 AEROLITE | Feb 24, 1995 | Substantially Equivalent |
| K940630 | 503 MAXI COMPRESSOR | Feb 21, 1995 | Substantially Equivalent |
| K905593 | SLEEPAP | Apr 23, 1991 | Substantially Equivalent |