FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SEAL RING FOR NASAL CPAP
K Number: K921499
·
Decision Sep 17, 1992
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
54
Applicant Total
29
Review Days
170
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Basic Information
- Device Name
- SEAL RING FOR NASAL CPAP
- K Number
- K921499
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5580
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Devilbiss Health Care, Inc.
- Date Received
- March 31, 1992
- Decision Date
- September 17, 1992
- Product Code
- BYG
- 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 |
|---|---|---|---|
| BYG | Mask, Oxygen | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BYG), ordered by most recent decision date.
FIRST AID KIT(S)
FDA 510(k)
FDA Class 1
·Anesthesiology
HANS RUDOLPH NASAL CPAP MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
DISPOSABLE, CPAP OXYGEN MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS
FDA 510(k)
FDA Class 1
·Anesthesiology
WESTMED PEDIATRIC AND ADULT AEROSOL MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Devilbiss Health Care, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K963349 | DEVILBISS 8650D | Jun 13, 1997 | Substantially Equivalent |
| K970289 | COMPRESSOR/NEBULIZER #3650 | Apr 15, 1997 | Substantially Equivalent |
| K961126 | PULSE DOSE SERIES | Oct 21, 1996 | Substantially Equivalent |
| K950849 | MODEL #7354 | Feb 8, 1996 | Substantially Equivalent |
| K952491 | MODEL 7355 | Jan 31, 1996 | Substantially Equivalent |
| K952249 | JET NEBULIZER | Jan 30, 1996 | Substantially Equivalent |
| K953815 | 5 LPM OXYGEN CONCENTRATOR | Nov 9, 1995 | Substantially Equivalent |
| K952037 | 3 LPM OXYGEN CONCENTRATOR | Sep 6, 1995 | Substantially Equivalent |
| K946095 | DEVILBISS MODEL 5500 | Aug 24, 1995 | Substantially Equivalent |
| K944611 | MODEL# 7500 SURVEYOR | Apr 21, 1995 | Substantially Equivalent |