FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
1ST RESPONSE DISPOSABLE MANOMETER
K Number: K961318
·
Decision Dec 17, 1996
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
77
Applicant Total
29
Review Days
256
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Basic Information
- Device Name
- 1ST RESPONSE DISPOSABLE MANOMETER
- K Number
- K961318
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2600
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Intertech Resources, Inc.
- Date Received
- April 5, 1996
- Decision Date
- December 17, 1996
- Product Code
- CAP
- 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 |
|---|---|---|---|
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | FDA class 2 | Anesthesiology |
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Other Clearances by Intertech Resources, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K921624 | DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITS | Jun 30, 1992 | Substantially Equivalent |