FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
UNIVERSAL VOLUME VENTILATOR CIRCUIT, MODIFICATION
K Number: K911328
·
Decision Aug 15, 1991
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
87
Applicant Total
29
Review Days
142
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Basic Information
- Device Name
- UNIVERSAL VOLUME VENTILATOR CIRCUIT, MODIFICATION
- K Number
- K911328
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5975
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Intertech Resources, Inc.
- Date Received
- March 26, 1991
- Decision Date
- August 15, 1991
- Product Code
- BZO
- 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 |
|---|---|---|---|
| BZO | Set, Tubing And Support, Ventilator (W Harness) | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
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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 |