FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ORAL-NASAL MASK RESUSCITATION AND ANESTHETIC GAS
K Number: K902298
·
Decision Aug 22, 1990
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
50
Applicant Total
11
Review Days
92
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Basic Information
- Device Name
- ORAL-NASAL MASK RESUSCITATION AND ANESTHETIC GAS
- K Number
- K902298
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5550
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Rondex Products, Inc.
- Date Received
- May 22, 1990
- Decision Date
- August 22, 1990
- Product Code
- BSJ
- 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 |
|---|---|---|---|
| BSJ | Mask, Gas, Anesthetic | FDA class 1 | Anesthesiology |
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Other Clearances by Rondex Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K981169 | RONDEX CPR ISO-SHIELD | May 19, 1998 | Substantially Equivalent |
| K942671 | CPR SHIELD | Feb 7, 1995 | Substantially Equivalent |
| K943761 | NON-BREATHING VALVE | Nov 10, 1994 | Unknown |
| K921002 | RONDEX MASK MODELS 9122/9111/9102/911102, MODIFIED | Oct 6, 1992 | Substantially Equivalent |
| K914195 | RONDEX CPR NON REBREATHING VALVE #9030, MODIFIED | Nov 8, 1991 | Substantially Equivalent |
| K914196 | RONDEX MASKS MODELS 9015/9011/901102 MODIFIED | Nov 8, 1991 | Substantially Equivalent |
| K902299 | CPR VALVE (NON-REBREATHING) MODEL #9030 | Oct 26, 1990 | Substantially Equivalent |
| K881931 | RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR | Jul 21, 1988 | Substantially Equivalent |
| K881393 | RONDEX RESCUE MASK | Apr 25, 1988 | Substantially Equivalent |
| K834250 | RESCUE MASK | Jan 18, 1984 | Substantially Equivalent |