FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MS-303-OXYGEN REGULATOR SHIELD
K Number: K810679
·
Decision Apr 17, 1981
Classifications
1
FEI Numbers
111
Registration Numbers
112
Same Product Code
54
Applicant Total
45
Review Days
35
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MS-303-OXYGEN REGULATOR SHIELD
- K Number
- K810679
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.2700
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Instrumentation Industries, Inc.
- Date Received
- March 13, 1981
- Decision Date
- April 17, 1981
- Product Code
- CAN
- 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 |
|---|---|---|---|
| CAN | Regulator, Pressure, Gas Cylinder | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CAN), ordered by most recent decision date.
MR Conditional CGA 870
FDA 510(k)
FDA Class 1
·Anesthesiology
PORTABLE OXYGEN UNIT SCA900
FDA 510(k)
FDA Class 1
·Anesthesiology
REMCORE REMOTE CONTROLLED OXYGEN REGULATOR
FDA 510(k)
FDA Class 1
·Anesthesiology
CYL-FIL OXYGEN SYSTEM
FDA 510(k)
FDA Class 1
·Anesthesiology
OXYGEN REGULATOR
FDA 510(k)
FDA Class 1
·Anesthesiology
VANGUARD SERIES GAS REGULATORS
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Instrumentation Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K180510 | NS 120P-TRS Airway Pressure Gauge | May 1, 2019 | Substantially Equivalent |
| K162753 | RTC 26-C Inline Aerosol Adapter | Feb 28, 2017 | Substantially Equivalent |
| K113644 | PILOT TUBE REPAIR KIT | Jan 26, 2012 | Substantially Equivalent |
| K102127 | ENDOTRACHEAL TUBE CHANGERS | Aug 27, 2010 | Substantially Equivalent |
| K101857 | RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V | Jul 22, 2010 | Substantially Equivalent |
| K091111 | RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC | Dec 2, 2009 | Substantially Equivalent |
| K081778 | NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS | Sep 12, 2008 | Substantially Equivalent |
| K081693 | NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS | Sep 11, 2008 | Substantially Equivalent |
| K991355 | METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE | Jan 27, 2000 | Substantially Equivalent |
| K992670 | OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067 | Sep 17, 1999 | Substantially Equivalent - Subject to Tracking Reg. |