GENERAL ANESTHESIA SYSTEM
FDA 510(k) clearance K944949 · decided 1994-11-14
Clearance details
- K-number
- K944949
- Device name
- GENERAL ANESTHESIA SYSTEM
- Applicant
- Vital Signs, Inc.
- Decision
- Unknown
- Date received
- 1994-10-07
- Decision date
- 1994-11-14
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- BTK
- Device class
- 1
- Regulation number
- 868.5560
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Totowa, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Vital Signs
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| STRAP, HEAD, GAS MASK (K914335) | Vital Signs, Inc. | 1992-04-02 |
| HEADSTRAP (K854537) | Life Design Systems, Inc. | 1985-12-03 |
| MEDIPART FACE MASK HEADSTRAP MP-9100 (K853573) | Medipart Jerry Alexander | 1985-10-29 |
| HEAD STRAP (K831008) | Medovations, Inc. | 1983-05-09 |
| HEADSTRAP (K810991) | Respironics, Inc. | 1981-04-29 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core t recall (Z-0407-2013) | Vital Signs Colorado Inc. | 2012-11-20 |