NASCOR IGLOO
FDA 510(k) clearance K935126 · decided 1994-10-18
Clearance details
- K-number
- K935126
- Device name
- NASCOR IGLOO
- Applicant
- Nascor Pty. , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1993-10-28
- Decision date
- 1994-10-18
- Days to decision
- 355 days
- Clearance type
- Traditional
- Product code
- BYL
- Device class
- 1
- Regulation number
- 868.5700
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Sydney Nsw, AU
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NASCOR OXYDOME (K905627) | Nascor Pty. , Ltd. | 1991-06-03 |
| SPAG PAK (K896608) | Viratek, Inc. | 1990-04-09 |
| DIRD INGANT O2 (BIO 2 HOOD) (K895866) | Bird Products Corp. | 1989-10-27 |
| NOVA OXYGEN TENT (K893713) | Nova Health Systems, Inc. | 1989-08-21 |
| KEYSTONE OXYGEN TENT (K893714) | Keystone Veterinary Supplies, Inc. | 1989-08-21 |
| AEROSOL DELIVERY HOOD (K882396) | Viratek, Inc. | 1988-08-01 |
| MEDI-COMP NEONATAL OXYGEN HOOD (K851666) | Medicomp, Inc. | 1985-08-06 |
| SEA-LONG NECKSEAL & HOOD (K852345) | Safety Sea Systems, Inc. | 1985-06-20 |
| HOO2D SEAT-INFANT (K820640) | Dhd Medical Products Div. Diemolding Corp. | 1982-03-26 |
| MEDIUM SIZE OXYGEN HOOD #1547 (K802653) | Ann Arbor Plastics, Inc. | 1980-11-24 |
Recalls involving this device
No recalls on record reference this clearance.