FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
XENON GAS BREATHING CIRCUIT
K Number: K952223
·
Decision Aug 11, 1995
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
47
Applicant Total
29
Review Days
91
Basic Information
- Device Name
- XENON GAS BREATHING CIRCUIT
- K Number
- K952223
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1390
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- INTERTECH RESOURCES, INC.
- Date Received
- May 12, 1995
- Decision Date
- August 11, 1995
- Product Code
- IYT
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IYT | System, Rebreathing, Radionuclide | FDA class 2 | Radiology |
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Other Clearances by INTERTECH RESOURCES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K961318 | 1ST RESPONSE DISPOSABLE MANOMETER | Dec 17, 1996 | Substantially Equivalent |
| K955008 | HEAT & MOISTURE EXCHANGER | Jan 30, 1996 | Substantially Equivalent |
| K953580 | HEAT MOISTURE EXCHANGER | Sep 15, 1995 | Substantially Equivalent |
| K952062 | PFT FILTER | Jun 8, 1995 | Substantially Equivalent |
| K952214 | SIMS INTERTECH HYPERINFLATION BAG SYSTEM | Jun 8, 1995 | Substantially Equivalent |
| K952169 | SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC | Jun 8, 1995 | Substantially Equivalent |
| K935036 | HEPA FILTERED HEAT AND MOISTURE EXCHANGER | Jan 25, 1994 | Unknown |
| K930816 | HEPA FILTERED HME | Jul 1, 1993 | Substantially Equivalent |
| K922479 | DISPOSABLE ANESTHESIA BREATHING CIRCUIT, MODIFIED | Oct 30, 1992 | Substantially Equivalent |
| K921624 | DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITS | Jun 30, 1992 | Substantially Equivalent |