FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITS
K Number: K921624
·
Decision Jun 30, 1992
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
21
Applicant Total
29
Review Days
85
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Basic Information
- Device Name
- DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITS
- K Number
- K921624
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5995
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Intertech Resources, Inc.
- Date Received
- April 6, 1992
- Decision Date
- June 30, 1992
- Product Code
- BYH
- 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 |
|---|---|---|---|
| BYH | Drain, Tee (Water Trap) | 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 |
| 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 |