FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
HEPA FILTERED HEAT AND MOISTURE EXCHANGER
K Number: K935036
·
Decision Jan 25, 1994
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
72
Applicant Total
29
Review Days
118
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Basic Information
- Device Name
- HEPA FILTERED HEAT AND MOISTURE EXCHANGER
- K Number
- K935036
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5375
- Medical Specialty
- Anesthesiology
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Intertech Resources, Inc.
- Date Received
- September 29, 1993
- Decision Date
- January 25, 1994
- Product Code
- BYD
- 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 |
|---|---|---|---|
| BYD | Condenser, Heat And Moisture (Artificial Nose) | FDA class 1 | Anesthesiology |
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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 |
| K952223 | XENON GAS BREATHING CIRCUIT | Aug 11, 1995 | Substantially Equivalent |
| K952062 | PFT FILTER | Jun 8, 1995 | Substantially Equivalent |
| K952169 | SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC | Jun 8, 1995 | Substantially Equivalent |
| K952214 | SIMS INTERTECH HYPERINFLATION BAG SYSTEM | Jun 8, 1995 | Substantially Equivalent |
| 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 |