Spectrum, Inc. 982-03924-001M
by Spectrum Co.
Spectrum, Inc. 982-03924-001M (781988M) is a Class II device made by Spectrum Co., cleared under FDA 510(k) K934630 on 28 Oct 1994 and listed in FDA GUDID since 30 Jan 2017 (UDI-DI 00850301007624), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850301007624 | Date30 Jan 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK934630 | Date28 Oct 1994 | StatusActive |
Official records
- AccessGUDID record 00850301007624
- FDA 510(k) database K934630
Across registries
- FDA 510(k) K934630 decided 28 Oct 1994 Active
- FDA GUDID UDI-DI 00850301007624 listed 30 Jan 2017 Listed
Timeline
- Cleared FDA 510(k) K934630
- Listed FDA GUDID 00850301007624
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Spectrum, Inc.
- Generic name
- Instrument/equipment drape, single-use, sterile
- Model / Ref / Catalog
- 982-03924-001M, 781988M
- Primary DI / UDI-DI
- 00850301007624
- 510(k) Number
- FDA product code
- KKX
- GMDN term
- Instrument/equipment drape, single-use, sterile
- Device class
- Class II
- Regulation number
- 878.4370
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Ethylene Oxide
- MRI safety
- MR Safe
Similar devices in this category
Other devices filed under Instrument/equipment drape, single-use, sterile.