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UltraviewSL

FDA UDI

Class II (US FDA UDI)

by Spacelabs Healthcare (washington), Inc

Identity

Trade Name
UltraviewSL FDA UDI
Generic Name
Patient monitoring system module, electroencephalographic FDA UDI
Device Name
OPTION, BISX BASE MODULE, REFURB FDA UDI
Model / Reference
91482 FDA UDI
Description
OPTION, BISX BASE MODULE, REFURB FDA UDI

Identifiers

Catalog Number
N/A FDA UDI
Primary DI / UDI-DI
10841522108754 FDA UDI
510(k) Number
K060900 FDA UDI
FDA Product Code
OLT FDA UDI
ORT FDA UDI
OMC FDA UDI
OLW FDA UDI
GMDN Term
Patient monitoring system module, electroencephalographic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1400 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Patient monitoring system module, electroencephalographic

UltraviewSL by Spacelabs Healthcare (washington), Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient monitoring system module, electroencephalographic.

Cleared under the same submission

K060900 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spacelabs Healthcare (washington), Inc

Sources (1)

  • FDA UDI b2b2d01e-35c6-4930-87ef-775d1915ab51 36 fields · synced May 30, 2026